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 2225 of 3531

510(k) clearances, page 2225 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K930840	Post-Myds(tm)	Aukland Medical Plastics, Inc.	HOY	Class I	1994-03-01
K926479	Bard Laparoscopic Irrigator Pump System	Davol, Inc.	GCJ	Class II	1994-03-01
K926305	Impla-Med Hex Screw Implants: 4,5 & 6Mm Diameter	The Stern Metals Co., Inc.	DZE	Class II	1994-03-01
K925414	Lateralase Catheter	Trimedyne, Inc.	GEX	Class II	1994-03-01
K925153	It-7 Femoral Component, Anatomic Hip System	Howmedica Corp.	KWY	Class II	1994-03-01
K925124	Trimedyne Model 1210 Omnipulse Holmium Lase Syst	Trimedyne, Inc.	GEX	Class II	1994-03-01
K925116	Electrosurgical Electrode	Premier	EKZ	Class II	1994-03-01
K924876	TENS Device for Relief of Chronic Pain, Modified	Graham-Field, Inc.	GZT	Class II	1994-03-01
K922497	Optilase Nd:yag Models 1000/4000 Surg Laser System	Trimedyne, Inc.	GEX	Class II	1994-03-01
K922496	Trimedyne Model 1210 Omnipulse Holmium Laser Syst	Trimedyne, Inc.	GEX	Class II	1994-03-01
K922394	Cardiofax Q ECG-8420A	Nihon Kohden America Inc	LOS		1994-03-01
K940284	Meddev Multarray Medical Examining Light Modification	Meddev International Corp.	KZF	Class I	1994-02-28
K940278	Aurium J	Argen Precious Metals, Inc.	EJT	Class II	1994-02-28
K940245	Evacu-Sled	Evacu Technologies, Inc.	FPP	Class I	1994-02-28
K935947	Hi-Tops Electrodes 14-8000	W. J. Medical Instruments, Inc.	KNF	Class II	1994-02-28
K935777	Sharpsafe, Cat. No. 4125	Smiths Industries Medical Systems, Inc.	FMI	Class II	1994-02-28
K935776	Sharpsafe, Cat. No. 4126	Smiths Industries Medical Systems, Inc.	FMI	Class II	1994-02-28
K935351	A.c. Power Patient Lift	Ken Kemmerer	FNG	Class II	1994-02-28
K935091	Aspen Surgical Systems Coated Blade Electrode	Conmedcorp	GEI	Class II	1994-02-28
K934772	Gastronomy Tube Holder	Nelmed Corp.	KNT	Class II	1994-02-28
K934409	Powder Free Latex Examination Gloves	Sjs Supreme, Inc.	LYY	Class I	1994-02-28
K934315	Endovations(r) .035 Pre-Cut Papillatome	Endovations	KNS	Class II	1994-02-28
K934291	Surgicot Fog Free	Ssa Aquisition Corp.	OCT	Class II	1994-02-28
K931957	Symbiosis Disposable Urological Biopsy Forceps	Boston Scientific Corporation	FCL	Class I	1994-02-28
K930859	Robi Combi	Epilady 2000, LLC	LJL	Class I	1994-02-28
K930217	Baxter Disposable Intraosseous Infusion Needle	Baxter Healthcare Corporation	FMI	Class II	1994-02-28
K926429	Vaginal Specula: Cusco, Guttman, Infant	Thomasville Medical Assoc.	HDF	Class I	1994-02-28
K926426	Powder Free Latex Examination Gloves	Dah Lee Investments, Ltd.	LYY	Class I	1994-02-28
K925114	Laparoscopic Instruments	Endo Technic Corp.	HFI	Class II	1994-02-28
K924148	Diamond-Sharp(r) Trocars	Snowden-Pencer	HFI	Class II	1994-02-28
K923570	Cryomedics Lletz Loops	Cabot Medical Corp.	HGI	Class II	1994-02-28
K940365	Manan Adapter for Bard Biopty System	Argon Medical Devices, Inc	KNW	Class II	1994-02-25
K940351	Extra Large Compress Dressing	Certified Safety Mfg Inc	EFQ	Unclassified	1994-02-25
K940348	Trauma Pad 5 X 9	Certified Safety Mfg Inc	EFQ	Unclassified	1994-02-25
K940345	Triangular Bandage	Certified Safety Mfg Inc	EFQ	Unclassified	1994-02-25
K940344	8 X 10 Non-Stick Pad	Certified Safety Mfg Inc	EFQ	Unclassified	1994-02-25
K940339	Iodoform Packaging Strip	Albahealth Products	FRO	Unclassified	1994-02-25
K940327	Intervent Allergen Exclusion Technology, Intervent Bedding System, Intervent Mattress Interliner, Interview Pillow	W. L. Gore & Associates, Inc.	FMW	Class I	1994-02-25
K940131	Table Mat Mortorized/electric	Med Mart, Inc.	INQ	Class I	1994-02-25
K940120	Alpha-Dent	Wallace A. Erickson & Co.	ELW	Class II	1994-02-25
K940025	Manan Bone Marrow Harvest Needles	Argon Medical Devices, Inc	GAA	Class I	1994-02-25
K940024	Manan General Purpose Introducer Needle	Argon Medical Devices, Inc	GAA	Class I	1994-02-25
K936013	Evatest Strip	Boehringer Mannheim Italia SpA	LCX	Class II	1994-02-25
K935920	Spectacle Frame	Cadore Moda USA, Inc.	HQY	Class I	1994-02-25
K935686	Dressing Change Tray	Cush Medical Products	LRO	Class II	1994-02-25
K935472	R & D Batteries, Inc. Part Number 5047	R & D Batteries, Inc.	FCO	Class I	1994-02-25
K935318	Summit Nuclear Vision Fx 20 Series Gamma Camera Systems	Summit Nuclear	KPS	Class II	1994-02-25
K935124	Bacticard Candida	Remel Inc	JXB	Class I	1994-02-25
K934640	Hmp Dual Polysulfone Port	Boston Scientific Corporation	LJT	Class II	1994-02-25
K934636	Annex Medical Flat Wire Stone Extractor	Annex Medical, Inc.	FFL	Class II	1994-02-25