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Assyro AI

Search 510(k) clearances

Search FDA 510(k) premarket notifications by text, applicant, product code and decision year, with facets and pagination.

POSThttps://api.assyro.com/v1/queryoperation: device-510k.search

Preview: api.assyro.com is not serving production data yet. Requests and responses on this page follow the published contract and may change before launch.

Searches 510(k) clearances. Returns up to 50 records per page with counts by filter value.

Input

  • querystringrequired

    The search text. Up to 2,048 characters.

  • applicantstring | nullrequired

    Only clearances from this applicant.

  • productCodestring | nullrequired

    Only clearances under this product code, such as FRN.

  • yearFrominteger | nullrequired

    Earliest decision year, 1900 to 9999.

  • yearTointeger | nullrequired

    Latest decision year. Must not be before yearFrom.

  • pageintegerrequired

    The page, from 1.

  • pageSizeintegerrequired

    Records per page, 1 to 50.

Each item in data.items

  • kNumberstringrequired

    The 510(k) number, such as K254199.

  • deviceNamestringrequired

    The device name as submitted.

  • applicantstring | nullrequired

    The company that submitted the 510(k).

  • productCodestring | nullrequired

    FDA's three-letter product code.

  • decisionDatedate | nullrequired

    When FDA decided.

  • decisionDescriptionstring | nullrequired

    The decision, such as Substantially Equivalent.

  • receivedDatedate | nullrequired

    When FDA received the submission.

  • advisoryCommitteestring | nullrequired

    The advisory committee.

  • statementOrSummarystring | nullrequired

    Whether a 510(k) statement or summary was filed.

  • submissionTypestring | nullrequired

    The submission type.

  • thirdPartyboolean | nullrequired

    Whether a third party reviewed it.

  • expeditedReviewboolean | nullrequired

    Whether review was expedited.

  • sourceobject

    Where the record comes from, when its source identity is available.