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 1733 of 3531

510(k) clearances, page 1733 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K991708	Zirconia 22.22Mm Ceramic Modular Heads	Zimmer GmbH	LZO	Class II	1999-07-30
K991625	Komet Xk-95 Perforator Motor (Mi-102)	Komet Medical	HBB	Class II	1999-07-30
K991615	Polyurethane Powder Free Dental Examination Glove, Polyurethane Powder Free Medical Examination Glove	Maxxim Medical	LZA	Class I	1999-07-30
K991581	Nexgen Complete Knee Solution Legacy Posterior Stabilized (Lps); Lps-Flex Fixed Bearing Femoral and Articular Surface Co	Zimmer GmbH	JWH	Class II	1999-07-30
K991546	Aktina Medical Physics Corporation Tilt Board	Aktina Medical Physics Corp.	IYE	Class II	1999-07-30
K991535	Convergence Cdr for Hitachi Spectradigital V250dsp Gamma Cameras	Hitachi Medical Corp. of America	KPS	Class II	1999-07-30
K991523	Tlc Pediatric Frame, Model Tlc-Sys	Radionics, Inc.	IYE	Class II	1999-07-30
K991520	Fresenius on Line Clearance Monitor with the Addition of Access Flow Determination	Fresenius Medical Care Renal Therapies Group, LLC	KDI	Class II	1999-07-30
K991073	Acier Sutures	Cardio Thoracic Systems	GAQ	Class II	1999-07-30
K990914	Polaris Diode Laser System and Accessories	Xintec Corporation	GEX	Class II	1999-07-30
K990770	Biorc Anchor	Linvatec Corporation	HWC	Class II	1999-07-30
K990680	Dentec Ld 15 Diode Laser	Dentek Lasersystems Produktions Ges.M.B.H.	GEX	Class II	1999-07-30
K990345	Rabea Device, Model Pxxxxxx	Signus Medizintechnik GmbH	JDK	Class II	1999-07-30
K990142	Ht, Model Ht Pb	Sulzer Oscor, Inc.	DTB	Class III	1999-07-30
K984482	Ave Gl-1 Guiding Catheter	Arterial Vascular Engineering Massachusetts, Inc.	DQY	Class II	1999-07-30
K984054	Agc V2 Revision Knee System	Zimmer GmbH	JWH	Class II	1999-07-30
K983802	Lmi Carotid Endarterectomy Shunt Catheter, Model #'S Ces, Cesr, Cesb, Cesrb, Cest, Cestr, Cestb, Cestrb, Ces-Sb, Cesr-Sb	Lucas Medical, Inc.	MJN	Class II	1999-07-30
K982859	Uc-Plus Solution Unicondylar Knee System	Plus Orthopedics	HRY	Class II	1999-07-30
K992300	Quick-Serter, Model 395	Medtronic, Inc.	KZH	Class II	1999-07-29
K992206	Powder-Free Vinyl Patient Examination Gloves	Shanghai China Star Corp	LYZ	Class I	1999-07-29
K992189	Gore-Tex Dualmesh Biomaterial	W. L. Gore & Associates, Inc.	FTL	Class II	1999-07-29
K992177	Nitrile Examination Gloves- Pre-Powdered, Small, Medium, and Large	Pt. Berlian Glovindo	LZA	Class I	1999-07-29
K992100	PVC (Polyvinyl Chloride) Synthetic Examination Gloves, Powdered	Shanghai Palomar Mountain Industries, Inc.	LYZ	Class I	1999-07-29
K991659	Uni-Laser 425P Diode Laser System & Accessories	MEDART ApS	GEX	Class II	1999-07-29
K991591	Biothane Patient Restraint	Bioplastics	FMQ	Class I	1999-07-29
K991533	Medtronic Ave Stent Delivery System - for Use in Biliary Indication	Peripheral Ave	FGE	Class II	1999-07-29
K991512	Asahi Am-R-Series Dialyzers (Modified), Model Am-Nr-X	Asahi Kasei Medical MT Corp. Oita Works	FJI	Class II	1999-07-29
K984506	Sd-100 Skyear Thermometer	Skylark Device Co., Ltd.	FLL	Class II	1999-07-29
K983120	Bicortical Screw	Oraltronics Marketing-Und Vertriebs GmbH	DZE	Class II	1999-07-29
K992197	Modification to Zymed Holter 2000	Zymed Medical Instrumentation	MLO	Class II	1999-07-28
K992167	Performance Knee System	Zimmer GmbH	JWH	Class II	1999-07-28
K991945	Pharmacia Cap System Ige Feia, Model 10-9395-01	Pharmacia & Upjohn Company LLC	DGC	Class II	1999-07-28
K991702	Microtainer Brand Chemistry Tubes with Microgard Closure, Model 365965, 365985, 365963, 365967, 36578	Becton Dickinson Vacutainer Systems	JKA	Class II	1999-07-28
K991503	Sacred Crane Tdp Lamp, Models Cq-27, Cq-12, Cq-36	united pacific Company	ILY	Class II	1999-07-28
K991497	Ics Medical Chartr Eng/vng Diagnostic System	Ics Medical Corp.	GWN	Class II	1999-07-28
K990580	Cryocheck La Sure, Model Sur25-10	Precision BioLogic Inc.	GIR	Class I	1999-07-28
K984501	Dade Behring Bftii	Siemens Healthcare Diagnostics Inc.	JPA	Class II	1999-07-28
K984188	Automated Cellular Imaging System (Acis)	Chroma Vision Medical Systems, Inc.	JOY	Class II	1999-07-28
K983270	Voyager Quad Cannula	Cardiothoracic Systems, Inc.	DWF	Class II	1999-07-28
K992251	Swiss Lithoclast Multipurpose Probe	E.M.S. - Electro Medical Systems SA	FFK	Class II	1999-07-27
K991517	Cryo-Hit II, Models Ep3t3, Ep5t2, Ep5t5, Ep7t5, Ep8t5	Galil Medical Ltd.	GEH	Class II	1999-07-27
K984627	Ave 4F Siteseer Cardiovascular Angiographic Catheter	Arterial Vascular Engineering, Inc.	DQO	Class II	1999-07-27
K992244	Greiner Minicollect Coagulation Blood Collection Tube	Greiner Meditech, Inc.	JKA	Class II	1999-07-26
K992216	Biomend Extend Absorbable Collagen Membrane, Biomend Absorbable Collagen Menbrane	Integra LifeSciences Corporation	LYC	Class II	1999-07-26
K992020	Brightway Brand Latex Surgical Gloves - Sterile (Powdered)	Brightsway Holdings Sdn Bhd	KGO	Class I	1999-07-26
K991951	Safeskin Synthetic Binyo Powder-Free Polymer Coated Examination Gloves (Green, White)	Safeskin Corp.	LYZ	Class I	1999-07-26
K991913	Pentamix 2	Espe Dental AG	EFD	Class I	1999-07-26
K991902	Lc Pit & Fissure Sealant	Bosworth Co.	EBC	Class II	1999-07-26
K991668	Compat Jejunostomy Tube Kit, Model 088Oxx (Xx=16,14, or 12)	Novartis Nutrition Corp.	KNT	Class II	1999-07-26
K991631	Fastray Lc	Harry J. Bosworth Co.	ELW	Class II	1999-07-26