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 1832 of 3531

510(k) clearances, page 1832 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K973474	Witt Biomedical Central Station Monitoring System and Witt Biomedical Advanced Patient Care Monitoring Units	Invivo Corporation	MHX	Class II	1998-03-13
K973405	Yeung Endoscopic Spine System	Richard Wolf Medical Instruments Corp.	HRX	Class II	1998-03-13
K973061	Ch-601A and Ch-601B Digital Wrist Sphygmomanometer (Ch-601A/ch-601B)	Citizen Watch Co., Ltd.	DXN	Class II	1998-03-13
K972749	Pao Bipolar Coaxial Coagulator (55-P15c/55-P18c/55-P18s/55-P19s/55-P20s)	C.M. Chance, Ltd.	HQR	Class II	1998-03-13
K972213	Ms-700	Alan S. Lee	DPW	Class II	1998-03-13
K971591	Indx Dip-S-Ticks Scrub Typhus Test for the Detection of Igg and Igm Antibodies to Orientia Tsutsugamushi (Scrub Typhus)	David C. Bishop, Ph.D.	LSQ	Class I	1998-03-13
K974796	Lithospec(tm) Intracorporeal Lithotripter	Medispec, Ltd.	FFK	Class II	1998-03-12
K974756	Bti Large (7.0Mm) Cannulated Transfixing Screws	Biodynamic Technologies, Inc.	HWC	Class II	1998-03-12
K973797	Breathing Circuit Bacterial Filter	King Systems Corporation.	CAH	Class II	1998-03-12
K973640	Ts2000 Medical Device Monitor	Trincore Systems, Inc.	MSX	Class II	1998-03-12
K973403	Cardiosmart St	Marquette Medical Systems, Inc.	LOS		1998-03-12
K971565	Bicoag Coagulating Forceps	Everest Medical Corp.	HIN	Class II	1998-03-12
K980532	Quickstream One Step Pregnancy Test Model Number 9012	Phamatech Inc.	LCX	Class II	1998-03-11
K980318	Powder-Free Latex Examination Gloves (Blue)	Hartalega Sdn Bhd	LYY	Class I	1998-03-11
K980291	Impower External Vacuum System	Imagyn Medical Technologies, Inc.	LKY	Class II	1998-03-11
K980195	Facebow	Ortho Kinetics Corp.	DZB	Class II	1998-03-11
K980133	Bausch & Lomb Wetting and Soaking Solution	Polymer Technology Corp.	LPN	Class II	1998-03-11
K980127	6 Inch Mini-Bone Extension Set with Luer Lock, Nes01s, 6 Inch Min-Bone Extension Set with Luer Slip, Nes02s, 6 Inch Stat	Catheter Innovations, Inc.	FPA	Class II	1998-03-11
K974805	Co-Stat(tm) End Tidal Breath Analyzer	Bio-Logic Systems Corp.	GHS	Class II	1998-03-11
K974780	Soflens(tm) One Day Disposable (Hilafilcon a) Visibility Tinted Contact Lens	Bausch & Lomb Incorporated	LPL	Class II	1998-03-11
K974697	Reusable Finger Sensor 3444	Bci Intl., Inc.	DQH	Class II	1998-03-11
K974671	Athena 20R S Type Slow Speed Handpiece Motor	Athena Technology, Inc.	EFB	Class I	1998-03-11
K974630	72 Hour Use Trach Care with Microban	Ballard Medical Products	CAH	Class II	1998-03-11
K974628	Frialit-2 Protect Abutment	Friatec AG	DZE	Class II	1998-03-11
K974360	Multitest Cd3/cd8/cd45/cd4	Becton Dickinson Immunocytometry Systems	GKZ	Class II	1998-03-11
K974160	Bruxtrak Material	Bruxcare, LLC	EBI	Class II	1998-03-11
K973999	Creatine Kinase-Sl Assay, Catalogue Number 326-10, 326-30	Sekisui Diagnostics P.E.I. Inc.	CGS	Class II	1998-03-11
K973800	23:1 Reduction Angle	Midwest Dental Products Corp.	EGS	Class I	1998-03-11
K973238	Zefon Adult Anesthesia Breathing Circuit with Filter, Zefon Pediatric Anesthesia Breathing Circuit with Filter	Bill Olson Corp.	CAH	Class II	1998-03-11
K973236	Crest Toothbrush with Microshield	Procter & Gamble Co.	EFW	Class I	1998-03-11
K972777	Temporary Occlusion Balloon System	Percu Surge, Inc.	MJN	Class II	1998-03-11
K972603	Electrocardiographs Models 110B, 120B and 310B	Dr. Lee Co., Ltd.	DPS	Class II	1998-03-11
K970662	Ca Cellulose Acetate Hollow Fiber Dialyzer (Ca-170/Ca-210)	Baxter Healthcare Corporation	MSF	Class II	1998-03-11
K970653	Cahp High Performance Cellulose Diacetate (Capillary, Hollow Fiber)	Baxter Healthcare Corporation	MSF	Class II	1998-03-11
K980160	Epilaser I Upgrade Kit	Palomar Medical Products, Inc.	GEX	Class II	1998-03-10
K980086	Heat Stack	Medical Solutions, Inc.	LGZ	Class II	1998-03-10
K980026	Glucose (Hk) - Incorporating Dynamic Stabilization Technology - (Dst)	Trace America, Inc.	CFR	Class II	1998-03-10
K974844	Outlook System Enhancement Package	Philips North America LLC	LNH	Class II	1998-03-10
K974781	Depuy Ace Aim(r) Titanium Supracondylar Nail	Depuy, Inc.	HSB	Class II	1998-03-10
K974734	Aurora Titanium Spinal Rod System	United States Surgical, A Division of Tyco Healthc	MNH	Class II	1998-03-10
K974723	Renu Multiplus Multi-Purpose Solution	Bausch & Lomb Incorporated	LPN	Class II	1998-03-10
K974708	Gemini Standard and Mini Valves	Neurocare Group	JXG	Class II	1998-03-10
K974703	Carbon Fiber Breast Board	Medtec LLC	IYE	Class II	1998-03-10
K974603	Plaquagrafe, Agrafe P4v	Atlas Technology	HRS	Class II	1998-03-10
K974174	Ultrabur	Mednet Locator, Inc.	ERL	Class II	1998-03-10
K973819	Vidas D-Dimer (Dd) Assay	Biomerieux Vitek, Inc.	DAP	Class II	1998-03-10
K973748	Tempo and Temp H20	Smith	LGZ	Class II	1998-03-10
K973679	Aeroetcher	Parkell, Inc.	KOJ	Class II	1998-03-10
K973508	Pylori Detect Igg	Micro Detect, Inc.	LYR	Class I	1998-03-10
K973377	Sibelmed Ac50d	Trutone	EWO	Class II	1998-03-10