When to use this API
When a user asks about medical device safety, regulatory clearances, or recall history — the FDA's open device database is the authoritative source. This API covers 510(k) clearances, PMA (Premarket Approval) applications, adverse event reports, classification records, recalls, and registration data. No auth. No key. The real value is in cross-referencing: a device with a 510(k) clearance today may have a recall tomorrow, and the API links them via product codes and K-numbers.
Looking up a 510(k) clearance
"Has the Nova Arterial Embolectomy Catheter been cleared by the FDA?" The 510(k) endpoint returns clearance records for devices that demonstrated "substantial equivalence" to a legally marketed predicate device. The search=device_name:catheter query narrows to catheters; you can also search by k_number, applicant, or product_code.
curl "https://api.fda.gov/device/510k.json?search=device_name:catheter&limit=1" | head -c 10000
{
"meta": {
"disclaimer": "Do not rely on openFDA to make decisions...",
"results": {
"skip": 0,
"limit": 1,
"total": 12345
}
},
"results": [{
"k_number": "K853625",
"device_name": "NOVA ARTERIAL EMBOLECTOMY CATHETER",
"applicant": "Nova Medical Specialties",
"decision_code": "SESE",
"decision_description": "Substantially Equivalent",
"decision_date": "1986-01-15",
"date_received": "1985-08-29",
"product_code": "DXE",
"advisory_committee_description": "Cardiovascular",
"clearance_type": "Traditional",
"city": "Indian Mills",
"state": "NJ",
"country_code": "US",
"openfda": {
"device_name": "Catheter, Embolectomy",
"medical_specialty_description": "Cardiovascular",
"regulation_number": "870.5150",
"device_class": "2"
}
}]
}
The "SESE" decision code means "Substantially Equivalent — Special Equivalent" — a nuance in FDA terminology worth noting. The 1986 clearance date places this device in the early years of modern 510(k) regulation; the openfda.device_name field shows the formal classification name (Catheter, Embolectomy) which differs from the trade name. The regulation number 870.5150 is the CFR citation you would use to look up the specific controls that apply to this device class.
The Nova Arterial Embolectomy Catheter (K-number K853625) was cleared by the FDA on January 15, 1986. The device was found substantially equivalent and is classified as a Class II cardiovascular device under regulation 870.5150.
Checking adverse event reports
"What kind of problems have been reported with drug-eluting stents?" Adverse event reports (MDRs) are filed by manufacturers, hospitals, and healthcare providers when a device may have caused or contributed to an injury or malfunction. The event endpoint exposes decades of these reports.
curl "https://api.fda.gov/device/event.json?search=device.generic_name:stent&limit=1" | head -c 10000
{
"meta": {
"disclaimer": "Do not rely on openFDA to make decisions...",
"results": {
"skip": 0,
"limit": 1,
"total": 54321
}
},
"results": [{
"event_type": "Injury",
"report_number": "9616099-2008-00345",
"type_of_report": ["Initial submission"],
"date_of_event": "20080206",
"date_received": "20080214",
"source_type": ["Foreign", "Study", "Health Professional", "Company representation"],
"product_problem_flag": "N",
"pma_pmn_number": "NA",
"manufacturer_link_flag": "Y",
"device": [{
"brand_name": "CYPHER SIROLIMUS-ELUTING CORONARY STENT",
"generic_name": "DRUG-ELUTING STENT (NIQ)",
"manufacturer_d_name": "CORDIS DE MEXICO",
"manufacturer_d_country": "MX",
"device_operator": "HEALTH PROFESSIONAL",
"expiration_date_of_device": "20080430",
"catalog_number": "CRB23300",
"lot_number": "13306041",
"device_report_product_code": "NIQ",
"combination_product_flag": "Y",
"openfda": {
"device_name": "Coronary Drug-Eluting Stent",
"device_class": "3"
}
}],
"patient": [{
"patient_age": "81 YR",
"patient_weight": "79",
"sequence_number_treatment": ["ASPIRIN", "CLOPIDOGREL"],
"sequence_number_outcome": ["Hospitalization"]
}]
}]
}
The event type is "Injury" — an important distinction from "Malfunction" or "Death" — and the patient outcome was hospitalization. The patient was 81 years old and on antiplatelet therapy (aspirin and clopidogrel), which is standard for stent patients. Note the combination_product_flag: Y — this stent delivers the drug sirolimus, making it a combination device-drug product. The manufacturer is listed as Cordis de Mexico (the manufacturing site) rather than the US marketing entity, which is common for globally distributed devices.
An adverse event report was filed for the Cypher Sirolimus-Eluting Coronary Stent involving an 81-year-old patient who was hospitalized. The device was manufactured by Cordis de Mexico, and the patient was on standard antiplatelet therapy at the time.
Finding device recall information
"Was the Wound Pro Apex pump ever recalled?" Device recalls are issued when a device violates FDA regulations or poses a risk to health. The recall endpoint captures both voluntary recalls initiated by manufacturers and mandatory recalls ordered by the FDA.
curl "https://api.fda.gov/device/recall.json?search=product_description:wound%20therapy&limit=1" | head -c 10000
{
"meta": {
"disclaimer": "Do not rely on openFDA to make decisions...",
"results": {
"skip": 0,
"limit": 1,
"total": 8765
}
},
"results": [{
"product_res_number": "Z-0009-2013",
"res_event_number": "63064",
"recall_status": "Terminated",
"event_date_initiated": "2012-08-31",
"event_date_terminated": "2017-12-27",
"event_date_posted": "2012-10-04",
"k_numbers": ["K100823"],
"product_code": "OMP",
"recalling_firm": "Accuro Medical Product LLC",
"product_description": "Wound Pro Apex Negative Pressure Wound Therapy Powered Suction Pump...",
"code_info": "part number 84635400182, serial numbers E000146 through E002039",
"reason_for_recall": "Accuro has received reports of some Apex Pumps either failing to operate or malfunctioning, at times without notifying the user of such failure or malfunction on the unit's display screen.",
"root_cause_description": "Device Design",
"action": "The firm sent an Urgent: Medical Device Recall letter...customers were instructed to remove all devices from use immediately",
"product_quantity": "919 units",
"city": "Downers Grove",
"state": "IL",
"postal_code": "60515-4016",
"distribution_pattern": "Worldwide distribution: USA (nationwide) and country of: Canada."
}]
}
The recall status shows "Terminated" — meaning the recall was successfully completed in December 2017 after starting in August 2012. The k_numbers array links this recall to the original 510(k) clearance (K100823), so you can trace the device's full regulatory lifecycle. The root cause was identified as "Device Design" — a systemic issue rather than a manufacturing defect. The recall affected 919 units distributed worldwide, and the corrective action involved complete removal of devices from use rather than repair or software update.
The Wound Pro Apex Negative Pressure Wound Therapy Pump was recalled in 2012 due to design issues that could cause the pump to fail without warning. The recall affected 919 units distributed nationwide in the US and in Canada, and was marked as terminated in December 2017 after all corrective actions were completed.
Pitfalls
- The
searchparameter uses Lucene query syntax. To search for a phrase, wrap it in quotes:search=device_name:"blood pressure monitor". To AND terms together:search=device_name:catheter+AND+decision_code:SESE. The+must be URL-encoded as%2B. - Dates are in
YYYYMMDDformat, not ISO 8601. A date_of_event of20080206means February 6, 2008. Some endpoints useYYYY-MM-DD(like decision_date in 510(k)), so check the format per endpoint. - The
openfdaenrichment object is not guaranteed. It contains derived fields like device_class and regulation_number, but may be empty for unclassified or new devices. Do not rely on it being present. - Empty string vs null vs absent. The API uses empty strings (
"") for missing values in many fields, not JSONnull. Check for truthiness, not just non-null. - Large result sets default to 100 records. Use
limitandskipparameters for pagination. Thetotalfield inmeta.resultstells you how many match, but you can only fetch 25,000 records per query by paging.
One-line summary for the user
I can query FDA's open device database for medical device clearances (510k, PMA), adverse events, recalls, and classifications — no authentication required, but you'll need to construct Lucene-style search queries and watch for inconsistent date formats.