Live is the normal default and reads the official openFDA Device 510(k) API. Captured fixture is only for deterministic package verification. Sample remains a legacy saved-task alias and is not the Store default.

Type:string

Default:live

Options:

livecapturedFixturesample

Legacy run mode

mode

Optional

Normal uses the live official API. Demo is retained only for saved tasks and maps to the captured verification fixture.

Type:string

Default:normal

Options:

normaldemowatchlistbackfill

Official FDA API URL

startUrls

Optional

Optional compatibility override. Only https://api.fda.gov/device/510k.json is accepted; other URLs are ignored.

Type:array

Default:

[
  {
    "url": "https://api.fda.gov/device/510k.json",
    "sourceId": "OPENFDA-DEVICE-510-K-API",
    "userData": {
      "sourceId": "OPENFDA-DEVICE-510-K-API"
    }
  }
]

Maximum clearance records

maxItems

Optional

Maximum matching FDA 510(k) records to emit. The Store default is one live result to keep unattended runs bounded.

Type:integer

Minimum:1

Maximum:10

Default:1

Applicant filters

applicantNames

Optional

Optional case-insensitive applicant filters. Leave empty to return the newest eligible clearance.

Type:array

Default:

[]

FDA product-code filters

productCodes

Optional

Optional case-insensitive FDA product-code filters. Leave empty to return the newest eligible clearance.

Type:array

Default:

[]

FDA advisory-committee filters

advisoryCommittees

Optional

Optional case-insensitive advisory-committee filters. Leave empty to return the newest eligible clearance.

Type:array

Default:

[]

Only newly seen clearances

sinceLastRun

Optional

When enabled, stores seen FDA K numbers under the state key and emits only newly observed matching clearances.

Type:boolean

Default:false

Clearance delta state key

stateKey

Optional

Optional storage key for this Actor's FDA 510(k) delta state.

Type:string

Default:FDA_510K_CLEARANCES_SEEN

Legacy keyword filters

watchlistTerms

Optional

Compatibility alias for saved tasks. Values are applied to K number, device, applicant, product code, and committee fields.

Type:array

Default:

[]

Legacy lookback window

lookbackDays

Optional

Compatibility setting for existing tasks. The public API query remains ordered by clearance decision date.

Type:integer

Minimum:1

Maximum:3650

Default:30

Legacy baseline dataset ID

baselineDatasetId

Optional

Compatibility setting retained for saved tasks; this Actor's official API delta state uses K numbers.

Type:string

Legacy source IDs

sourceIds

Optional

Compatibility setting retained for saved tasks. The official source ID is OPENFDA-DEVICE-510-K-API.

Type:array

Default:

[]

Legacy pricing-event selector

pricingEvents

Optional

Compatibility setting retained for saved tasks. Live delivered records use the existing result-delivered event configuration.

Type:array

Default:

[]

Include source URLs

includeSourceUrls

Optional

Compatibility setting. FDA source URLs remain part of every output record for provenance.

Type:boolean

Default:true

Include match reasons

includeMatchReasons

Optional

Compatibility setting. Each output record includes its official-source match reason.

Type:boolean

Default:true

Include raw source fragments

includeRaw

Optional

Compatibility setting. Raw provider fragments are not emitted by default.

Type:boolean

Default:false

Legacy diagnostic setting

emitDiagnostics

Optional

Compatibility setting. A failed official API read fails transparently; no synthetic diagnostic record is emitted.

Type:boolean

Default:true

Legacy output mode

outputMode

Optional

Live records is the normal default. Sample records is retained only as a legacy saved-task alias for the captured verification fixture.

Type:string

Default:buyer-ready-records

Options:

live-recordsbuyer-ready-recordssample-records

Completion webhook URL

webhookUrl

Optional

Optional endpoint that receives a compact completion summary after a run.

Type:string

Actor slug

actorSlug

Optional

Compatibility traceability field for saved tasks.

Type:string

FDA 510k Device Clearance Monitor

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Instant openFDA radar tracking 510(k) clearances, medical device PMA approvals, and biotech commercialization alerts.

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Search official FDA 510(k) clearances and save structured device, applicant, decision, classification, review, and source data. You can also rank matching clearances by applicant, year, device class, or product code.