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 2193 of 3531

510(k) clearances, page 2193 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K940376	Qms Gentamicin Assay	Seradyn, Inc.	LCD	Class II	1994-06-02
K940374	Qms Carbamazepine Assay	Seradyn, Inc.	KLT	Class II	1994-06-02
K940347	Trocars, Cannulae and Sheaths for Endoscopic and Laparoscopic Procedures	Karl Storz Endoscopy-America, Inc.	GCJ	Class II	1994-06-02
K940269	Hollister Non-Rolled Self-Adhesive Urinary External Catheter	Hollister, Inc.	EXJ	Class I	1994-06-02
K935413	Ena Eia Test Kit	David A. Fuccillo, Ph.D.	LLL	Class II	1994-06-02
K934436	Sbp Dental Unit	Northland Dental Engineering	EIA	Class I	1994-06-02
K934116	Wallstent Tracheobronchial Prosthesis Modification	Boston Scientific Corporation	JCT	Class II	1994-06-02
K934007	Sofamor Orfil Spine Fixation System	Sofamor Co.	KWP	Class II	1994-06-02
K932606	Apolipoprotien a-1 (Apo a-1)	Sigma Diagnostics, Inc.	JHN	Class I	1994-06-02
K932603	Apolipoprotien B (Apo B)	Sigma Diagnostics, Inc.	JHN	Class I	1994-06-02
K932047	Wavicide Monitor Strips	Serim Research Corp.	MED	Class II	1994-06-02
K922481	Browne Ga Indicator Use in 2% Activ Glutaraldehyde	Board of Directors, Albert Browne, Ltd.	JOJ	Class II	1994-06-02
K932310	Kit Pak Incontinent Skin Care Kit	Kit Pak, Inc.	EYQ	Class I	1994-06-01
K931541	Model 26-0375, Electrosurgical Generator	Cameron-Miller, Inc.	HGI	Class II	1994-06-01
K941485	Cardiometrics Flowire Doppler Guide Wires	Cardio Metrics, Inc.	DQX	Class II	1994-05-31
K941125	Novagel Silicone Gel Sheeting	Brennen Medical, Inc.	MDA	Class I	1994-05-31
K940636	Conbio Medlite Q-Switched Nd:yag Laser System	Continuum Biomedical, Inc.	GEX	Class II	1994-05-31
K940607	Conbio Medlite Q-Switched Nd:yag Laser System	Continuum Biomedical, Inc.	GEX	Class II	1994-05-31
K936260	Transit Infusion Catheter	Cordis US Corp.	DQO	Class II	1994-05-31
K931814	Dmi Uterine Mobilizer/elevator/cannula	Diversified Medical Instruments, Inc.	LKF	Class II	1994-05-31
K942366	Lorrex Gauze Sponges, X-Ray Detectable	Lorrex Health Products	GDY	Class I	1994-05-27
K942357	H-500 Alliance Oxygen Concentrator	Healthdyne, Inc.	CAW	Class II	1994-05-27
K942207	Reflex Ins Insufflation Needle	Richard-Allan Medical	HIF	Class II	1994-05-27
K942198	Cu-80 Light Cure Unit, Document No. A715676	Rolence Enterprise Co., Ltd.	EBZ	Class II	1994-05-27
K942141	Eidolon Endoscope Coupler	Eidolon Corp.	FET	Class II	1994-05-27
K942014	Sterile Water Wet Dressing	Trinity Laboratories, Inc.	MGF		1994-05-27
K941925	Ortho-Jet Acrylic Resin - Sparkle	Lang Dental Mfg Co, Inc.	EBI	Class II	1994-05-27
K941370	Bausch & Lomb Medalist 66 (Alphafilcon a) Visibility Tinted Contact Lens	Bausch & Lomb Incorporated	LPL	Class II	1994-05-27
K941326	Ultrafree-Cl	EMD Millipore Corporation	JJH	Class I	1994-05-27
K941032	Unknown	Gelman Sciences, Inc.	FMF	Class II	1994-05-27
K940967	Modified Endopath Ils	Ethicon Endo-Surgery Inc	OCW	Class II	1994-05-27
K940860	Chromaclone Color Changing Alginate Impress Materials	Ultradent Products Inc.	ELW	Class II	1994-05-27
K940422	Igg Subclass Single Dilution Diagnostic Kit for Use with the Beckman Array Analyzer	The Binding Site	DFZ	Class II	1994-05-27
K940220	Rebreather Bags	Zefon Medical Products	BTC	Class I	1994-05-27
K940160	Ts1000 Portable Disposable Cold Therapy System	Burke Neutech, Inc.	ILO	Class II	1994-05-27
K940159	Cedia Dau Benzodiazepine Assay	Microgenics Corporation	JXM	Class II	1994-05-27
K936038	Slt Laser Continuous Flow Tesectoscope (CFR)	Surgical Laser Technologies, Inc.	FJL	Class II	1994-05-27
K935655	Abl5 Blood Gas System	Radiometer America, Inc	CHL	Class II	1994-05-27
K935434	Obstetric-Gynecologic Specialized Manual Instrument	United States Surgical, A Division of Tyco Healthc	LKF	Class II	1994-05-27
K935121	Abl System 620	Radiometer America, Inc	CHL	Class II	1994-05-27
K933799	Ten-20 Conductive Paste Gel	Cadwell Laboratories, Inc.	GYB	Class II	1994-05-27
K932222	Slt Femoral Head	Dow Corning Wright	LZO	Class II	1994-05-27
K932123	Implant Innovation Pre-Angled Abutment System	Implant Innovations International, Inc.	DZE	Class II	1994-05-27
K931444	Plexus 2 & 3.5 Hollow Fiber Oxygenators	Sorin Biomedica, Fiat, USA, Inc.	DTZ	Class II	1994-05-27
K931437	Model 80-1983, Electrosurgical Generator	Cameron-Miller, Inc.	HGI	Class II	1994-05-27
K925010	Nebulizer Pump, Powered, Model 1110	Thomas Industries	BTI	Class II	1994-05-27
K942312	Alden Lineage Wheelchair Cushion	Lewis W. Ward	KNN	Class I	1994-05-26
K942260	Alden Wheelchair Cushion	Ward and Assoc.	KNN	Class I	1994-05-26
K941931	Diagnostic X-Ray Patient Exposure Indicator	Victoreen, Inc.	KPR	Class II	1994-05-26
K941685	Disposable Filtered Insufflation Tubing Set	Blue Planet Industries, Inc.	HIF	Class II	1994-05-26