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 2197 of 3531

510(k) clearances, page 2197 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K940504	Spectacle Frames	Tecnol-Tecnica Nacional de Oculos Ltda	HQZ	Class I	1994-05-17
K940311	Sunglasses and Sport Sunglasses	Lanner Enterprise Co., Ltd.	HQY	Class I	1994-05-17
K940183	Hy-Tec Total Ige Enzyme Immunoassay	Hycor Biomedical	DGC	Class II	1994-05-17
K936109	Sharplan Model 1120 CO2 Surgical Laser	Sharplan Lasers, Inc.	GEX	Class II	1994-05-17
K936102	Davol Laparoscopic Insufflation Needle for General Laparoscopic Procedures	Davol Inc., Sub. C.R. Bard, Inc.	GCJ	Class II	1994-05-17
K935608	Mamospat	E.V.S. Tool & die Co., Inc.	IZH	Class II	1994-05-17
K935563	Sharplan Surgical CO2 Lasers and Accessories	Sharplan Lasers, Inc.	GEX	Class II	1994-05-17
K935518	Moving Images(tm)	Epm Information Systems, Inc.	BZQ	Class II	1994-05-17
K935422	Sunlovers, Charles Jourdan, Courreges Sunglasses	Sunlovers Sunglasses	HQY	Class I	1994-05-17
K935308	Accucolor(tm) Antithrombin III Chromogenic Assay	Sigma Diagnostics, Inc.	JBQ	Class II	1994-05-17
K934659	Sunglass	South American Plastic Manufactory Co., Ltd.	HQY	Class I	1994-05-17
K934269	Fiberoptic Illuminated Instruments	Visitec Co.	HJM	Class II	1994-05-17
K934211	Cytocare Diode Laser System	Cytocare, Inc.	GEX	Class II	1994-05-17
K934142	Urinary Drainage Bag	Key Medical Services, Inc.	EXR	Class II	1994-05-17
K933987	Aor-Tex Vascular Graft	W. L. Gore & Associates, Inc.	DSY	Class II	1994-05-17
K933797	Omni Prep Gel	Cadwell Laboratories, Inc.	GYB	Class II	1994-05-17
K933719	Bioscrew Absorbable Interference Screw	Linvatec Corporation	HWC	Class II	1994-05-17
K926248	Reader	Alamar Biosciences Laboratory, Inc.	LRH	Class I	1994-05-17
K923524	Volumetric Rendering Technique Option	Siemens Medical Solutions USA, Inc.	JAK	Class II	1994-05-17
K922711	Flexible Fiber Optic Gynecologic Endoscope	Optimed Technologies, Inc.	HIH	Class II	1994-05-17
K942061	Disposable Suction Probe	United States Surgical, A Division of Tyco Healthc	JOL	Class II	1994-05-16
K941967	Hsw Laparoscope and Accessories	Henke-Sass Wolf, GmbH.	GCJ	Class II	1994-05-16
K941672	Uri-Cath Catheter	Gesco Intl., Inc.	GBM	Class II	1994-05-16
K941565	Jarit Recommended Sinus Instruments	J. Jamner Surgical Instruments, Inc.	EOB	Class II	1994-05-16
K941541	Hsv Laparoscopy Set	Henke Sass Wolf of America, Inc.	GCJ	Class II	1994-05-16
K941364	Acufex T-Fix Rotator Cuff Guide Systems	Acufex Microsurgical, Inc.	HRX	Class II	1994-05-16
K941189	Disposable Prophylaxis Angle	Team Technologies, Inc.	EGS	Class I	1994-05-16
K941134	Emc2 Lens Fog Reduction Solution & Cleaning Kit	H & C Chemical, Inc.	FEB	Class II	1994-05-16
K941035	Venoscope	Trinity Partners, LLC	HJN	Class I	1994-05-16
K940985	Acufex(r) Arthroplasty Instruments	Acufex Microsurgical, Inc.	HRX	Class II	1994-05-16
K940981	Acufex Linear/rotary Instruments	Acufex Microsurgical, Inc.	HRX	Class II	1994-05-16
K940911	Basics Endoscopy System	Cox Medical Ent., Inc.	KGE	Class II	1994-05-16
K940710	Stryker Microdebrider System	Stryker Corp.	ERL	Class II	1994-05-16
K940218	Suresoft Surgical Gloves	BD Becton Dickinson Vacutainer Systems Preanalytic	KGO	Class I	1994-05-16
K936279	Galileo Endoscopes	Galileo Electro-Optics Corp.	GCJ	Class II	1994-05-16
K936248	Medicon Instruments Cholangiography Needles, Guide Tubes, Injection Needles, Verres Insufflation Needles and Holders	Medicon Instruments, Inc.	GCJ	Class II	1994-05-16
K936058	Optodent/optognath	Spectrum Healthcare Group	ELM	Class II	1994-05-16
K935971	Flowgun Electrocautery Probes	O.R. Concepts, Inc.	GEI	Class II	1994-05-16
K935970	Flowgun Electrocautery Probe Handle	O.R. Concepts, Inc.	GEI	Class II	1994-05-16
K934783	Kavo Intrasept 905	Kavo America	EIA	Class I	1994-05-16
K934697	Microvasive Maxforce	Boston Scientific Corporation	KNQ	Class II	1994-05-16
K933674	Ongard 2 Gallon Chemo Sharps Container	Ongard Systems, Inc.	FMI	Class II	1994-05-16
K933567	Euroform Total Hip Prosthesis	Landos, Inc.	LZO	Class II	1994-05-16
K933274	Ongard 3 Quart Sharps Container	Ongard Systems, Inc.	FMI	Class II	1994-05-16
K933102	Howmedica Acetabular Shell W/screw Holes	Howmedica Corp.	LPH	Class II	1994-05-16
K931573	Vesphene II	Calgon Vestal Div.	LRJ	Class I	1994-05-16
K930667	Reusable Laparoscopic Instruments	Snowden-Pencer	GCJ	Class II	1994-05-16
K924631	Cabot Medical Uterine Resectoscope	Cabot Medical Corp.	HIH	Class II	1994-05-16
K923711	Perioflex Tip	Novadent, Ltd.	EFS	Class I	1994-05-16
K941764	Hichem Calcium Reagent for the Synchron Cx3 Prod. No. 88808	Hi Chem, Inc.	CJY	Class II	1994-05-13