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 2026-10-12, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,969 of the 176,366 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	2,569

176,366 records, page 3308 of 3528

510(k) clearances, page 3308 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K810443	Limb Orthosis	Fred Sammons, Inc.	IQI	Class I	1981-03-04
K810442	Hand Splints and Components	Fred Sammons, Inc.	ILH	Class I	1981-03-04
K810439	Body Strap	Fred Sammons, Inc.	KNO	Class I	1981-03-04
K810436	Tracheostoma Vent	Bivona Medical Technologies	BTO	Class II	1981-03-04
K810402	Ace Cold Bandage	BD Becton Dickinson Vacutainer Systems Preanalytic	IME	Class I	1981-03-04
K810391	Vogler Hysterectomy Forceps (Small & Lg)	Edward Weck, Inc.	HCZ	Class II	1981-03-04
K810389	Earette Hearing Aid Sears Model 8053	Oticon, Inc.	ESD	Class I	1981-03-04
K810379	Earette Hearing Aid Sears #8054	Oticon, Inc.	FSD	Class I	1981-03-04
K810321	Reinforced Tracheostomy Tube Set(tentat)	National Catheter Co. Div. Mallinckrodt	BTO	Class II	1981-03-04
K810320	Heatpac	Shinsei Corp.	IMB	Class II	1981-03-04
K810312	Elecath Dual Mode Transthoracic Pacing	Electro-Catheter Corp.	LDF	Class II	1981-03-04
K810292	Cam-Wrap	MEDLINE INDUSTRIES, LP - Northfield	FTA	Class II	1981-03-04
K810289	Modulus Verni-Trol Anesthetic Vaporizer	Ohio Medical Products	CAD	Class II	1981-03-04
K810273	Davol Electro Medical Systems	C.R. Bard Inc	GEI	Class II	1981-03-04
K810245	Implantable Pacemaker Lead Adapter	Intermedics, Inc.	DTD	Class II	1981-03-04
K810219	Prefilled Humidifer	Corpak Co.	BTT	Class II	1981-03-04
K810218	Prefilled Nebulizer	Corpak Co.	CAF	Class II	1981-03-04
K810217	Nebulizer Heater	Corpak Co.	CAF	Class II	1981-03-04
K810143	Tampax Deodorant Tampons	Tampax, Inc.	HIL	Class II	1981-03-04
K810096	Porcelain Powder for Clinical Use	Dentsply Intl.	EIH	Class II	1981-03-04
K810074	Accuflo 100	Renal Care Corp.	KOC	Class II	1981-03-04
K810031	Stereo Auditory Trainer (Model Pm228)	Hc Electronics	EPF	Class II	1981-03-04
K803256	Eyetech-Vision Screening System	Eyedex	HOX	Class I	1981-03-04
K803171	Procedure & Recovery Patient Suit	Alba Health Care	FYB	Class II	1981-03-04
K803068	Nikkiso Nd-14 Parallel Flow Dialyzer	Nikkiso Co., Ltd.	FJG	Class II	1981-03-04
K802368	Option 301 Pacemaker Eval. Module Mac-1	Marquette Electronics, Inc.	DPS	Class II	1981-03-04
K810393	Endoscopic Closed Circuit Color Tv Syst.	Keymed, Inc.	FET	Class II	1981-03-02
K810190	Opti 110/12/50Hsg	Siemens Corp.	ITY	Class I	1981-03-02
K810189	Sirecon Compact	Siemens Corp.	JAA	Class II	1981-03-02
K810156	Argyle Salem Sump Tube	Sherwood Medical Co.	KNT	Class II	1981-03-02
K803099	Biofeedback Bio 80	Bimed, Inc.	HCC	Class II	1981-03-02
K803049	Digital Radiography Chest Device	Philips North America LLC	KPR	Class II	1981-03-02
K810485	Dujovny Microsurgical Scissors	American V. Mueller	GZX	Class I	1981-02-27
K810441	Universal Gonimeter	Fred Sammons, Inc.	KQW	Class I	1981-02-27
K810363	Ear Oximeter	Bio-Tek Instruments, Inc.	DPZ	Class II	1981-02-27
K810300	Fiber Optic Adapters#60-0893	Aspen Laboratories, Inc.	HBI	Class II	1981-02-27
K810299	Fiber Optic Adapters#60-0891	Aspen Laboratories, Inc.	HBI	Class II	1981-02-27
K810098	Fox Eye Shields	American Hospital Supply	HOY	Class I	1981-02-27
K803282	Guardian Monitor (Cardiovascular)	BD Becton Dickinson Vacutainer Systems Preanalytic	DSI	Class II	1981-02-27
K810434	Gamma-Gt Reagent System	American Monitor Corp.	JQB	Class I	1981-02-26
K810411	Portable Oxygen Generator	Supplemental Oxygen Systems, Inc.	CAW	Class II	1981-02-26
K810405	Cholesterol Reagent	Gilford Diagnostics	CHH	Class I	1981-02-26
K810381	Htsh Riabead Diagnostic Kit	Abbott Medical	CGJ	Class I	1981-02-26
K810375	Centurion Stopcock 3 Way	Centurion Medical Products, LP	FMG	Class II	1981-02-26
K810337	Pdi Surgical Scrub Sponge-Brush-T15070	Nice-Pak Products, LLC	GEC	Class I	1981-02-26
K810318	Parke-Davis Non-Woven Sponge	Hospital Products Co.	NAB	Class I	1981-02-26
K810303	Television Camera Holder for Surgery	The Anspach Effort, Inc.	FXR	Class I	1981-02-26
K810294	Line Caddy	Instranetics, Inc.	HXB	Class I	1981-02-26
K810282	Operating Table Accessory Clamp	Minnesota Scientific, Inc.	GBJ	Class I	1981-02-26
K810269	Omed Fabric Instrument Covers	Omega-Med Intl., Inc.	KDC	Class I	1981-02-26