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 2153 of 3531

510(k) clearances, page 2153 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K943278	Tracker 2/Tracker 3 Holter Recorder	Reynolds Medical, Ltd.	DSH	Class II	1994-10-20
K943241	Dma Glucose (Oxidase) Procedure	Data Medical Associates, Inc.	CGA	Class II	1994-10-20
K943188	Sealite Science, Inc. Aqualite(r) Lh	Sealite Sciences, Inc.	CEP	Class I	1994-10-20
K943019	Cedia T4 Mab Assay	Microgenics Corporation	KLI	Class II	1994-10-20
K942610	Kodak Extachem Clinical Chemistry Slide Digoxin (Dgxn)	Eastman Kodak Company	LFM	Class II	1994-10-20
K942328	N Latex RF	Behring Diagnostics, Inc.	DHR	Class II	1994-10-20
K942162	Sigma 8000 and Sigma 8002	Sigma Intl.	FRN	Class II	1994-10-20
K941765	Hcg Pregnancy One Step Test Strip for OTC Use	Tcpi, Inc.	LCX	Class II	1994-10-20
K941391	Inflatable Retention Cuff Speculum	Innovatec Medical Corp.	GBT	Class II	1994-10-20
K936126	Howmedics Drg Femoral Component	Howmedica Corp.	JDI	Class II	1994-10-20
K936087	Carpal Box	Innovative Medical Technologies, Inc	KPR	Class II	1994-10-20
K935726	Exactech Porous Coated Cruciate Retained Femoral Component	Exactech, Inc.	JWH	Class II	1994-10-20
K935394	Mac-Lab Electrophysiology Module Option	Marquette Electronics, Inc.	DPS	Class II	1994-10-20
K934429	Anterior Spine System	Buckman Co., Inc.	KWQ	Class II	1994-10-20
K933743	Ssa-380A	Toshiba America Medical Systems, In.C	IYN	Class II	1994-10-20
K932776	Cruciate Retaining Cemented Tibial Components	Exactech, Inc.	JWH	Class II	1994-10-20
K932760	Dfs-2100	dba Systems, Inc.	LMA	Class II	1994-10-20
K944855	Chromophare	Berchtold Holding GmbH	FSY	Class II	1994-10-19
K944738	Series 600 Centrifuge-Four Separate Variations of the Same Base Centrifuge	Ducker CL	JQC	Class I	1994-10-19
K944517	Pasco Mic and Mic/id Panels	Pasco Laboratories, Inc.	JWY	Class II	1994-10-19
K944494	Alsa-Klenz	Calgon Vestal Div.	FLG	Class I	1994-10-19
K943734	Medical Support Stockings 2001/2002	Julius Zorn GmbH	DWL	Class II	1994-10-19
K943539	Aims Cannulated Acl Screw	Smith & Nephew, Inc.	HWC	Class II	1994-10-19
K942461	Neurology Accessories - Mark-Easy 10-20	Optimit USA, Inc.	GXY	Class II	1994-10-19
K941787	Latex Exam Gloves	P.T. Irama Dinamika Latex	LYY	Class I	1994-10-19
K935321	Innovasive Suture Bone Fastener with Suture	Innovasive Devices, Inc.	JDR	Class II	1994-10-19
K935280	Memotherm 10 Baby Thermometer	International Regulatory Consultants	FLL	Class II	1994-10-19
K935113	J.b.s. Implantable Spinal Fixation Device	J.B.S., S.A.	KWP	Class II	1994-10-19
K934323	Dried Gram-Positive Mic/combo Panels, Amp/ext Dil	Baxter Diagnostics, Inc.	JWY	Class II	1994-10-19
K944565	Kls-Martin Micro Osteosythesis System(1.5mm)	KLS-Martin L.P.	JEY	Class II	1994-10-18
K944561	Micro Osteosynthesis System (1.0)	KLS-Martin L.P.	JEY	Class II	1994-10-18
K944560	Man Surg Instr/access to Kls-Martin Micro Osteo Syst	KLS-Martin L.P.	JEY	Class II	1994-10-18
K944510	Vinyl Examination Glove, Powder-Free	American Gemini, Inc.	LYZ	Class I	1994-10-18
K943817	Marquette Adult/neonatal Wrap Sensor	Marquette Electronics, Inc.	DQA	Class II	1994-10-18
K943644	Implantech Temporal Implant	Implantech Associates Inc	FWP	Class II	1994-10-18
K943598	Flexible Fiber Optic Laparoscopes	Optimed Technologies, Inc.	HET	Class II	1994-10-18
K942670	Gc Pattern Resin	GC America Inc.	EBG	Class II	1994-10-18
K942476	Protectaide Biohazard Clean-Up Kit No. B3069	Protectaide, Inc.	FXX	Class II	1994-10-18
K942475	Protectaide Personal Protection Pack No. 12351	Protectaide, Inc.	FXX	Class II	1994-10-18
K942474	Protectaide Personal Protection Pack No. 18000	Protectaide, Inc.	FXX	Class II	1994-10-18
K942473	Protectaide Personal Protection Pack No. 24592	Protectaide, Inc.	FXX	Class II	1994-10-18
K942472	Protectaide Personal Protection Pack No. 26123	Protectaide, Inc.	FXX	Class II	1994-10-18
K942471	Protectaide Biohazard Clean-Up Kit No. 29777	Protectaide, Inc.	FXX	Class II	1994-10-18
K942470	Protectaide Personal Protection Pack No. 08315	Protectaide, Inc.	FXX	Class II	1994-10-18
K942293	Ms Classique Balloon Catheter	Meadox Medicals, Div. Boston Scientific Corp.	LIT	Class II	1994-10-18
K942269	Medtronic Everest Inflation Device	Medtronics Interventional Vascular	MAV	Class II	1994-10-18
K941706	Opti-Plast Angioplasty Catheter	Vas-Cath, Inc.	LIT	Class II	1994-10-18
K940957	Hemochron Verigy System/factor VI Qualify System	Accriva Diagnostics, Inc.	JPA	Class II	1994-10-18
K935597	Fasguide Catheter	Target Therapeutics	DQY	Class II	1994-10-18
K935349	Localmed Infusion Catheter	Localmed, Inc.	KRA	Class II	1994-10-18