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 2026-11-02, 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 2530 of 3531

510(k) clearances, page 2530 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K902263	Optilase Model 1000 Nd:yag Laser Add'l Indication	Trimedyne, Inc.	GGX	Class I	1990-07-23
K902065	E.t. Tape II	B & B Medical Technologies, Inc.	CBH	Class I	1990-07-23
K901845	Tegaderm Brand Transparent Dressing Series 16Xx	3M Company	KGX	Class I	1990-07-23
K901530	Wallace Intrauterine Insemination Catheter	Gynescope Corp.	EJT	Class II	1990-07-23
K901406	Anatomic Modular Knee (Amk) Posterior Stabilized	Depuy, Inc.	JWH	Class II	1990-07-23
K901313	Instruments for Neurological Surgery	Von Zeppelin GmbH	HAE	Class II	1990-07-23
K901308	Spiro Analyzer Model St 250	Futuremed Div. of Future Impex Corp.	BZG	Class II	1990-07-23
K896536	Pharmatronics Nebulizer	Diversatronics, Inc.	CAF	Class II	1990-07-23
K894228	Kronner Spherical Cutters	Kronner Medical	HWT	Class I	1990-07-23
K902022	Seal Rite(tm)	Pulpdent Corporation	EBC	Class II	1990-07-20
K902007	I3system-Abd	Innovative Imaging, Inc.	IYO	Class II	1990-07-20
K901874	Coatest Lmw Heparin/heparin Chromogenic Assay	Kabi Diagnostica	KFF	Class II	1990-07-20
K901860	Intra III and Intra IV Hearing Aids	Starkey Laboratories, Inc.	ESD	Class I	1990-07-20
K901655	1 Transducer for Combison 310A	Kretztechnik AG	ITX	Class II	1990-07-20
K901553	Surg-K Surgical Keratometer	The Sanborn Co.	HLR	Class I	1990-07-20
K901512	L Sophia	Nishitomo Co., Inc.	LHD	Unclassified	1990-07-20
K901185	Foley Catheter Insertion Tray (10Cc)	Orion Life Systems, Inc.	FCM	Class II	1990-07-20
K901184	Urethral Catheter Tray (Latex)	Orion Life Systems, Inc.	FCM	Class II	1990-07-20
K901183	Urethral Catheter Tray (PVC)	Orion Life Systems, Inc.	FCM	Class II	1990-07-20
K901181	Catheter Care Tray	Orion Life Systems, Inc.	FCM	Class II	1990-07-20
K901180	Foley Catheter Insertion Tray (30Cc)	Orion Life Systems, Inc.	FCM	Class II	1990-07-20
K902890	Aspen 3 Oxygen Concentrator	Mountain Medical Equipment, Inc.	CAW	Class II	1990-07-19
K902719	Spect.e.n.s. Repostion.-E Foam Pin Type TENS Elect	Labeltape Meditect, Inc.	GXY	Class II	1990-07-19
K902698	Affinity Prolactin Test System	BD Becton Dickinson Vacutainer Systems Preanalytic	CFT	Class I	1990-07-19
K902679	Models 4201, 4231 & 4235 Extension Cables	Pace Medical	DTE	Class II	1990-07-19
K902630	Bilateral Tmj Coil	Resonex, Inc.	LNH	Class II	1990-07-19
K902616	Bilirubin Control	Phoenix Diagnostics, Inc.	JJY	Class I	1990-07-19
K902592	Epc Electronic Pipetting System	Ulster Scientific, Inc.	JQW	Class I	1990-07-19
K902580	Emit(r) II Barbiturate Assay	Syva Co.	DIS	Class II	1990-07-19
K902409	Becton Dickinson 360 Infuser (Tm) System	BD Becton Dickinson Vacutainer Systems Preanalytic	FRN	Class II	1990-07-19
K902344	Ati Disposable Biological Test Pack for Steam Ster	Ati	FRC	Class II	1990-07-19
K902300	Easy Breather Model 100 Accessories	Progressive Productions, Ltd.	BYT	Class II	1990-07-19
K902293	Angiography Drape Pack	Biocor Medical, Inc.	LRO	Class II	1990-07-19
K902257	Codman* External Drainage System II (Eds-II)	Cerenovus, Inc.	JXG	Class II	1990-07-19
K902180	Tracheal Tube Stylet	Sims Surgical, Inc.	BSR	Class I	1990-07-19
K902094	Blood Gas/ise Controls	Phoenix Diagnostics, Inc.	JJY	Class I	1990-07-19
K902036	Steri-Vac Gas Sterilizer Model 5Xl	3M Company	FLF	Class II	1990-07-19
K902035	Flexible Extender	Beacon Laboratories, Inc.	GEI	Class II	1990-07-19
K901802	Toy Sunglasses	Sirco Intl. Corp.	HQY	Class I	1990-07-19
K901706	Light, Head, Examination	Burton Medical Products Corp.	KZF	Class I	1990-07-19
K901527	Biuret (Colormetric), Total Protein	American Research Products Co.	CEK	Class II	1990-07-19
K901382	Isoflo(tm) High Pressure Injection Lines	Healthdyne Cardiovascular, Inc.	DXT	Class II	1990-07-19
K901040	Ionometer Eh-F and Accessories	Fresenius USA, Inc.	JGS	Class II	1990-07-19
K900087	Genesys 6000 Gamma Counter	Laboratory Technologies, Inc.	JJJ	Class I	1990-07-19
K896364	Decident	Nevin Laboratories, Inc.	EKY	Class I	1990-07-19
K895923	Metricare Enteral Feeding System	The Metrix Company	FPD	Class II	1990-07-19
K895770	Exel Huber Infusion Set	Exel Intl.	FPA	Class II	1990-07-19
K902850	Zeppelin Instruments	Ruggles Corp.	HAO	Class I	1990-07-18
K902759	Cobe Closed Wound Drainage Kit	Cobe Laboratories, Inc.	CAC	Class II	1990-07-18
K902590	Threaded Paddle Pairs, Internal Adult Pedi Infant	Marquette Electronics, Inc.	LDD	Class II	1990-07-18