Medical Device Knowledge Graph

The Medical Device Knowledge Graph converts public U.S. Food and Drug Administration (FDA) device data into one linked RDF graph of about 1.29 billion triples (release v0.0.5, October 2026). Sources include product classification, 510(k) and De Novo clearances, PMA approvals and supplements, Humanitarian Device Exemptions, Devices@FDA decisions, establishment registration and listing, the Global Unique Device Identification Database (5.2 million device records), the full MAUDE adverse-event history (26.1 million reports), recall enforcement reports and the recall database (59,471 recalls, 99% with a recall class), Total Product Life Cycle summaries, Section 522 postmarket studies, recognized consensus standards, CLIA test categorizations, home-use IVD tests, mammography facilities, X-ray assembler reports, and all of Title 21 of the Code of Federal Regulations.

Records join through shared nodes: FDA product code, regulation number, firm (FEI number), and device identifier (UDI-DI). Recall product descriptions that quote a GS1 barcode are linked to the matching UDI device record, so a recall can be traced to specific catalog items. Establishments carry Census geocodes, and product codes are mapped to NAICS industries. Vocabulary terms are under https://bmedesign.org/medical-device-kg/ns/ and instances under https://bmedesign.org/medical-device-kg/id/.

Personal details are removed from MAUDE narrative text, and contact persons are not ingested from any source. The graph supports device safety surveillance, recall and adverse-event analysis, regulatory research, and teaching in biomedical engineering design.

Main classes and keys. mdkg:RecallRecord (recall number, mdkg:recallClassification "Class I/II/III", initiation and termination dates, root cause, mdkg:codeInfo lot text), mdkg:MAUDEReport, mdkg:UDIDeviceRecord and mdkg:UDIIdentifier (UDI-DI in mdkg:identifierId), mdkg:K510Record, mdkg:PMARecord, mdkg:ProductCode (FDA three-letter code in mdkg:productCode), mdkg:Manufacturer (FDA FEI number), mdkg:RegistrationListingRecord (registered establishments), and mdkg:TPLCRecord (MAUDE totals per product code). Recalls link to devices through mdkg:hasProductCode, mdkg:relatedK510Record, mdkg:relatedPMARecord, mdkg:hasRecallingManufacturer and, for quoted barcodes, mdkg:mentionsDeviceIdentifier.

Joining with other OKN graphs. Addresses carry mdkg:postalCode (ZIP), mdkg:city and mdkg:state; establishments carry mdkg:name and WGS84 coordinates from the US Census geocoder. Product codes and manufacturers map to NAICS industries through sudokn:hasNAICSClassifier (an inferred crosswalk, labelled as such). These support joins by ZIP code with place-based graphs and by NAICS industry or firm name with manufacturing graphs.

Responsible use. MAUDE is passive surveillance: report counts are not failure rates, FDA does not verify causation, and the absence of reports is not evidence of safety.