510(k) clearances

Premarket notifications cleared by FDA, newest decision first.

Every 510(k) record MDM has ingested from openFDA. Each clearance page carries the record as FDA published it, the product code it was cleared under, recalls sharing that product code, and a link to the FDA source.

Data as of 2026-11-05, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,132 of the 176,529 ingested clearances have a decision year between 2012 and 2026, the 15 years shown, 2023 the highest year at 3,346.

Show the numbers

510(k) clearances by decision year, the last 15 years of ingested records
Year	Clearances
2012	3,135
2013	3,052
2014	3,202
2015	3,020
2016	2,956
2017	3,200
2018	3,062
2019	2,918
2020	2,923
2021	3,023
2022	3,209
2023	3,346
2024	3,129
2025	3,225
2026	2,732

176,529 records, page 2336 of 3531

510(k) clearances, page 2336 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K914862	Cerebrovascular Diagnostic System; Cds	Medasonics, Inc.	IYN	Class II	1992-12-03
K914119	Davol Orthopaedic Autotransfusion System	Davol, Inc.	CAC	Class II	1992-12-03
K913618	Arbovirus Igm Ifa Test	Hillcrest Biologicals	GQC	Class I	1992-12-03
K913617	Arbovirus Igg Ifa Test	Hillcrest Biologicals	GQC	Class I	1992-12-03
K913096	Sam Sc	Ferguson Medical	CAF	Class II	1992-12-03
K913095	Sam Ls	Ferguson Medical	CAF	Class II	1992-12-03
K922222	Angiographic X-Ray System	Siemens Medical Solutions USA, Inc.	IZI	Class II	1992-12-02
K915833	Sensormedics Model 2600 Pediatric Pulmoonary Cart	Sensor Medics Corp.	BZC	Class II	1992-12-02
K924907	Filtermate Universal Harvester	Packard Instrument Co., Inc.	JTC	Class I	1992-12-01
K924843	Immunodot(r) Ena/dna Autoimmunity Screening Panel	General Biometrics, Inc.	LLL	Class II	1992-12-01
K924545	Micro Mode-Trans Electrical Neural Stimulator	Mod Mode Medical	GZJ	Class II	1992-12-01
K924405	Control Plasma P	Behring Diagnostics, Inc.	GGC	Class II	1992-12-01
K924404	Clibration Plasmas	Behring Diagnostics, Inc.	GGN	Class II	1992-12-01
K924395	Neothromitin(r)	Behring Diagnostics, Inc.	GPO	Class I	1992-12-01
K924394	Clotting Factor V Deficient Plasma	Behring Diagnostics, Inc.	GJT	Class II	1992-12-01
K924173	Hemocard(tm) Control	Isolab, Inc.	JCM	Class II	1992-12-01
K924124	Behring Fibrintimer a	Behring Diagnostics, Inc.	JPA	Class II	1992-12-01
K924044	Ventrex Allergen Disc	Hycor Biomedical	DHB	Class II	1992-12-01
K924036	Accutex Rheumatiod Factor (RF) Latex Test	J.S. Medical Assoc.	DHR	Class II	1992-12-01
K923768	Pulse Crp Test	Pulse Scientific, Inc.	DCK	Class II	1992-12-01
K922654	Ventilator Adult Star Modification	Infrasonics Corp.	CBK	Class II	1992-12-01
K922623	Nebulizer System	Healthdyne, Inc.	BTI	Class II	1992-12-01
K922064	Model #510 Stealth-Plate Dispersive Electrode	Cardiotronics, Inc.	GXD	Class II	1992-12-01
K921870	Encore Sm/rnp	Trinity Biotech USA	LLL	Class II	1992-12-01
K921572	Encore Sm	Trinity Biotech USA	LLL	Class II	1992-12-01
K921132	Syn Elisa Dsdna Antibodies	Elias U.S.A., Inc.	LKJ	Class II	1992-12-01
K915686	Model 2900 Metabolic Measurement Cart	Sensor Medics Corp.	BZC	Class II	1992-12-01
K913714	Modification Manual Pulmon Resuscitor/pulmanex(tm)	Life Design Systems, Inc.	BTM	Class II	1992-12-01
K925177	Vidas Free Thyroxine(ft4) Assay	Biomerieux Vitek, Inc.	CEC	Class II	1992-11-30
K924963	Olympus Direct Bilirubin Reagent	Olympus Corp.	CIG	Class II	1992-11-30
K924846	Remel Cefaclor 30Mcg Susceptibility Disk	Remel Inc	JTN	Class II	1992-11-30
K924500	Antimicrobial Susceptibility Test	Alamar Biosciences Laboratory, Inc.	JWY	Class II	1992-11-30
K924421	Synelisa Cardiolipin Antibodies	Elias U.S.A., Inc.	MID	Class II	1992-11-30
K924257	Testosterone Serozyme(tm) Enzyme Immunoassay	Serono-Baker Diagnostics, Inc.	CDZ	Class I	1992-11-30
K924209	Ventrex Allergen Disc	Hycor Biomedical	DHB	Class II	1992-11-30
K924119	Ventrex Allergen Disc	Ventrex, Inc.	DHB	Class II	1992-11-30
K923536	Nuclear Medicine Laser Imager	General Scanning, Inc.	LMC	Class II	1992-11-30
K923401	Delfia Htsh Ultra Kit	Wallac Oy	JLW	Class II	1992-11-30
K922933	Sorin Monolyrh Integrated Membrane Lung	Sorin Biomedica, Fiat, USA, Inc.	DTZ	Class II	1992-11-30
K922241	Autozyme	Cambridge Life Sciences PLC.	LLL	Class II	1992-11-30
K920358	Ultracell Nasal Packing	Ultracell Medical Technologies, Inc.	EMX	Class I	1992-11-30
K925679	Vena Cava Filter Systems, Modification	B. Braun Vena-Tech	DTK	Class II	1992-11-27
K925332	Bennett X-Ray Id Plus	Bennett X-Ray Technologies	JAC	Class I	1992-11-27
K925175	Shimadzu X-Ray Diagnostic Table Ysf-200 30/90	Shimadzu Medical Systems	IXR	Class II	1992-11-27
K925174	Shimadzu Radiographic Table Bk-100	Shimadzu Medical Systems	IZZ	Class II	1992-11-27
K924604	Storz Reus 20/25 Gauge Vitre Cut W/reus Hand/driv	Storz Instrument Co.	HQE	Class II	1992-11-27
K924430	Ax-300Se Automatic X-Ray Film Processor, 6586.027	Alphatek Corp.	IXW	Class II	1992-11-27
K924349	General Purpose Flex Coil, Catalog Number M1685gp	General Electric Co.	LNH	Class II	1992-11-27
K924345	Radiographic Film Marketing System	Fischer Imaging Corp.	JAC	Class I	1992-11-27
K924229	Vg-a Mig	Vortech Data, Inc.	LMD	Class I	1992-11-27