openFDA · Capability

openFDA API — Device

openFDA API — Device. 9 operations. Lead operation: 510(k) clearances. Self-contained Naftiko capability covering one openFDA business surface.

openFDA API — Device is a Naftiko capability published by openFDA, one of 6 capabilities the APIs.io network indexes for this provider. It bundles 9 operations across the GET method rooted at /v1/device.

The capability includes 9 read-only operations. Lead operation: 510(k) clearances. Can be deployed as a REST endpoint, MCP tool, or Agent Skill via Naftiko.

Tagged areas include openFDA and Device.

Run with Naftiko openFDADevice

What You Can Do

GET
Searchdevice510k — 510(k) clearances
/v1/device/510k-json
GET
Searchdeviceclassification — Device product classifications
/v1/device/classification-json
GET
Searchcovid19serology — COVID-19 serology testing data
/v1/device/covid19serology-json
GET
Searchdeviceenforcement — Device recall enforcement reports
/v1/device/enforcement-json
GET
Searchdeviceevents — Device adverse events (MAUDE)
/v1/device/event-json
GET
Searchdevicepma — Premarket Approval (PMA) records
/v1/device/pma-json
GET
Searchdevicerecalls — Device recalls
/v1/device/recall-json
GET
Searchdeviceregistrationlisting — Device registrations and listings
/v1/device/registrationlisting-json
GET
Searchdeviceudi — Unique Device Identifier (UDI) database
/v1/device/udi-json

MCP Tools

510-k-clearances

510(k) clearances

read-only idempotent
device-product-classifications

Device product classifications

read-only idempotent
covid-19-serology-testing-data

COVID-19 serology testing data

read-only idempotent
device-recall-enforcement-reports

Device recall enforcement reports

read-only idempotent
device-adverse-events-maude

Device adverse events (MAUDE)

read-only idempotent
premarket-approval-pma-records

Premarket Approval (PMA) records

read-only idempotent
device-recalls

Device recalls

read-only idempotent
device-registrations-and-listings

Device registrations and listings

read-only idempotent
unique-device-identifier-udi-database

Unique Device Identifier (UDI) database

read-only idempotent

Capability Spec

openfda-device.yaml Raw ↑ 
naftiko: 1.0.0-alpha2
info:
  label: openFDA API — Device
  description: 'openFDA API — Device. 9 operations. Lead operation: 510(k) clearances. Self-contained Naftiko capability covering
    one openFDA business surface.'
  tags:
  - openFDA
  - Device
  created: '2026-05-19'
  modified: '2026-05-19'
binds:
- namespace: env
  keys:
    OPENFDA_API_KEY: OPENFDA_API_KEY
capability:
  consumes:
  - type: http
    namespace: openfda-device
    baseUri: https://api.fda.gov
    description: openFDA API — Device business capability. Self-contained, no shared references.
    resources:
    - name: device-510k.json
      path: /device/510k.json
      operations:
      - name: searchdevice510k
        method: GET
        description: 510(k) clearances
        outputRawFormat: json
        outputParameters:
        - name: result
          type: object
          value: $.
    - name: device-classification.json
      path: /device/classification.json
      operations:
      - name: searchdeviceclassification
        method: GET
        description: Device product classifications
        outputRawFormat: json
        outputParameters:
        - name: result
          type: object
          value: $.
    - name: device-covid19serology.json
      path: /device/covid19serology.json
      operations:
      - name: searchcovid19serology
        method: GET
        description: COVID-19 serology testing data
        outputRawFormat: json
        outputParameters:
        - name: result
          type: object
          value: $.
    - name: device-enforcement.json
      path: /device/enforcement.json
      operations:
      - name: searchdeviceenforcement
        method: GET
        description: Device recall enforcement reports
        outputRawFormat: json
        outputParameters:
        - name: result
          type: object
          value: $.
    - name: device-event.json
      path: /device/event.json
      operations:
      - name: searchdeviceevents
        method: GET
        description: Device adverse events (MAUDE)
        outputRawFormat: json
        outputParameters:
        - name: result
          type: object
          value: $.
    - name: device-pma.json
      path: /device/pma.json
      operations:
      - name: searchdevicepma
        method: GET
        description: Premarket Approval (PMA) records
        outputRawFormat: json
        outputParameters:
        - name: result
          type: object
          value: $.
    - name: device-recall.json
      path: /device/recall.json
      operations:
      - name: searchdevicerecalls
        method: GET
        description: Device recalls
        outputRawFormat: json
        outputParameters:
        - name: result
          type: object
          value: $.
    - name: device-registrationlisting.json
      path: /device/registrationlisting.json
      operations:
      - name: searchdeviceregistrationlisting
        method: GET
        description: Device registrations and listings
        outputRawFormat: json
        outputParameters:
        - name: result
          type: object
          value: $.
    - name: device-udi.json
      path: /device/udi.json
      operations:
      - name: searchdeviceudi
        method: GET
        description: Unique Device Identifier (UDI) database
        outputRawFormat: json
        outputParameters:
        - name: result
          type: object
          value: $.
    authentication:
      type: apikey
      key: api_key
      value: '{{env.OPENFDA_API_KEY}}'
      placement: query
  exposes:
  - type: rest
    namespace: openfda-device-rest
    port: 8080
    description: REST adapter for openFDA API — Device. One Spectral-compliant resource per consumed operation, prefixed with
      /v1.
    resources:
    - path: /v1/device/510k-json
      name: device-510k-json
      description: REST surface for device-510k.json.
      operations:
      - method: GET
        name: searchdevice510k
        description: 510(k) clearances
        call: openfda-device.searchdevice510k
        outputParameters:
        - type: object
          mapping: $.
    - path: /v1/device/classification-json
      name: device-classification-json
      description: REST surface for device-classification.json.
      operations:
      - method: GET
        name: searchdeviceclassification
        description: Device product classifications
        call: openfda-device.searchdeviceclassification
        outputParameters:
        - type: object
          mapping: $.
    - path: /v1/device/covid19serology-json
      name: device-covid19serology-json
      description: REST surface for device-covid19serology.json.
      operations:
      - method: GET
        name: searchcovid19serology
        description: COVID-19 serology testing data
        call: openfda-device.searchcovid19serology
        outputParameters:
        - type: object
          mapping: $.
    - path: /v1/device/enforcement-json
      name: device-enforcement-json
      description: REST surface for device-enforcement.json.
      operations:
      - method: GET
        name: searchdeviceenforcement
        description: Device recall enforcement reports
        call: openfda-device.searchdeviceenforcement
        outputParameters:
        - type: object
          mapping: $.
    - path: /v1/device/event-json
      name: device-event-json
      description: REST surface for device-event.json.
      operations:
      - method: GET
        name: searchdeviceevents
        description: Device adverse events (MAUDE)
        call: openfda-device.searchdeviceevents
        outputParameters:
        - type: object
          mapping: $.
    - path: /v1/device/pma-json
      name: device-pma-json
      description: REST surface for device-pma.json.
      operations:
      - method: GET
        name: searchdevicepma
        description: Premarket Approval (PMA) records
        call: openfda-device.searchdevicepma
        outputParameters:
        - type: object
          mapping: $.
    - path: /v1/device/recall-json
      name: device-recall-json
      description: REST surface for device-recall.json.
      operations:
      - method: GET
        name: searchdevicerecalls
        description: Device recalls
        call: openfda-device.searchdevicerecalls
        outputParameters:
        - type: object
          mapping: $.
    - path: /v1/device/registrationlisting-json
      name: device-registrationlisting-json
      description: REST surface for device-registrationlisting.json.
      operations:
      - method: GET
        name: searchdeviceregistrationlisting
        description: Device registrations and listings
        call: openfda-device.searchdeviceregistrationlisting
        outputParameters:
        - type: object
          mapping: $.
    - path: /v1/device/udi-json
      name: device-udi-json
      description: REST surface for device-udi.json.
      operations:
      - method: GET
        name: searchdeviceudi
        description: Unique Device Identifier (UDI) database
        call: openfda-device.searchdeviceudi
        outputParameters:
        - type: object
          mapping: $.
  - type: mcp
    namespace: openfda-device-mcp
    port: 9090
    transport: http
    description: MCP adapter for openFDA API — Device. One tool per consumed operation, routed inline through this capability's
      consumes block.
    tools:
    - name: 510-k-clearances
      description: 510(k) clearances
      hints:
        readOnly: true
        destructive: false
        idempotent: true
      call: openfda-device.searchdevice510k
      outputParameters:
      - type: object
        mapping: $.
    - name: device-product-classifications
      description: Device product classifications
      hints:
        readOnly: true
        destructive: false
        idempotent: true
      call: openfda-device.searchdeviceclassification
      outputParameters:
      - type: object
        mapping: $.
    - name: covid-19-serology-testing-data
      description: COVID-19 serology testing data
      hints:
        readOnly: true
        destructive: false
        idempotent: true
      call: openfda-device.searchcovid19serology
      outputParameters:
      - type: object
        mapping: $.
    - name: device-recall-enforcement-reports
      description: Device recall enforcement reports
      hints:
        readOnly: true
        destructive: false
        idempotent: true
      call: openfda-device.searchdeviceenforcement
      outputParameters:
      - type: object
        mapping: $.
    - name: device-adverse-events-maude
      description: Device adverse events (MAUDE)
      hints:
        readOnly: true
        destructive: false
        idempotent: true
      call: openfda-device.searchdeviceevents
      outputParameters:
      - type: object
        mapping: $.
    - name: premarket-approval-pma-records
      description: Premarket Approval (PMA) records
      hints:
        readOnly: true
        destructive: false
        idempotent: true
      call: openfda-device.searchdevicepma
      outputParameters:
      - type: object
        mapping: $.
    - name: device-recalls
      description: Device recalls
      hints:
        readOnly: true
        destructive: false
        idempotent: true
      call: openfda-device.searchdevicerecalls
      outputParameters:
      - type: object
        mapping: $.
    - name: device-registrations-and-listings
      description: Device registrations and listings
      hints:
        readOnly: true
        destructive: false
        idempotent: true
      call: openfda-device.searchdeviceregistrationlisting
      outputParameters:
      - type: object
        mapping: $.
    - name: unique-device-identifier-udi-database
      description: Unique Device Identifier (UDI) database
      hints:
        readOnly: true
        destructive: false
        idempotent: true
      call: openfda-device.searchdeviceudi
      outputParameters:
      - type: object
        mapping: $.