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Assyro AI

Get a 510(k) clearance

Read one FDA 510(k) clearance by its K number: device, applicant, product code, decision and source.

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

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.

Returns one clearance. An unknown K number is 404 record_not_found.

Input

  • idstringrequired

    The K number, such as K254199.

data.record

  • 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.