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 2026-10-15, 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 3103 of 3528

510(k) clearances, page 3103 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K833637	Vzv Bio-Enzabead Screen Kit	Bionetic Laboratory Products	LFY	Class II	1984-02-10
K833483	Endoscopic Coupler	Merrimack Laboratories	EOQ	Class II	1984-02-10
K833430	Blood Gas Expersystem 8700	Medical Intelcom, Inc.	LLE	Class III	1984-02-10
K833428	Implantable Unipolar Cardiac Pulse Gen	Telectronics, Inc.	DXY	Class III	1984-02-10
K833427	Implantable Bipolar Cardiac Pulse Gen	Telectronics, Inc.	DXY	Class III	1984-02-10
K833375	Dual Purpose Catheter	Jinotti Ent Inc. Medical	BSY	Class I	1984-02-10
K833132	Mucosal Adjustment Paste Liquid Spray	Myo-Tronics Research, Inc.	EFH	Class I	1984-02-10
K832986	Pap Smear Brush	Donald G. Zeller	HHT	Class II	1984-02-10
K832555	Ocumap 100 Autoperimeter	Shorashim	HPT	Class I	1984-02-10
K840286	Brooker External Fixation Frame	Depuy, Inc.	JDW	Class II	1984-02-09
K840250	Carrier	Convaid Products LLC	LBE	Class I	1984-02-09
K840100	Patella Prosthesis	Techmedica, Inc.	JWH	Class II	1984-02-09
K840046	Pressurizing/scavenging Acrylic Cement	Precision Medical Devices, LLC	KIH	Class I	1984-02-09
K834488	Merrittan Sun System	Interfit A.G. Dba/Int'L Tanning Sys	FTC	Class II	1984-02-09
K834462	Genucom	Far Orthopedics, Inc.	LYH	Class I	1984-02-09
K833907	Creighton Fixator	Patton Machine Co.	JDW	Class II	1984-02-09
K833780	Capd Prep Kit	Professional Dialysis Products	FKG	Class I	1984-02-09
K833524	Sunbed/sunroof Tanning Device	J B Trading BV	FTC	Class II	1984-02-09
K833438	Prepacell-Sterile-Bone Marrow Aspir	Applied Medical Devices, Inc.	KDD	Class I	1984-02-09
K833160	Hdl Ez-Tab	Preventive Diagnostics Corp.	LBR	Class I	1984-02-09
K840545	Pao Bipolar Coagulator	Cimarron Instruments, Inc.			1984-02-08
K833256	Crouch Corneal Protector	Star Instrument Co.	HOY	Class I	1984-02-08
K833557	Medilas Laser	Endo Lase, Inc.	LNK	Class II	1984-02-07
K840743	Redy 2000	bioMerieux, Inc.			1984-02-06
K834495	UV-a Suntanning Equipment 1000-8000	Futuren, Inc.	FTC	Class II	1984-02-06
K840313	Cat. 9 Anesthesiology Respiratory Dev	Imm Enterprises, Ltd.	BWB	Class I	1984-02-04
K840282	Overhead Whirlpool Hand Spa Brand	Priest Enterprises, Inc.	ILJ	Class II	1984-02-04
K840280	Road Runner Electric Treadmill	Battle Creek Equipment	IOL	Class I	1984-02-04
K840264	Servo Cart 170	Siemens Elema AB	BZN	Class I	1984-02-04
K840205	Dryden Mini Bacteria Filter	Dryden Corp.	CAH	Class II	1984-02-04
K840167	Portable Defibrillator	Honeywell, Inc.	LDD	Class II	1984-02-04
K840166	Sur-Fit Urostomy Pouch W/accuseal	Convatec, A Division of E.R. Squibb & Sons	EXB	Class I	1984-02-04
K840146	Exp* 700 Parallel Plate Dialyzer	Extracorporeal Medical Specialities, Inc.	KOC	Class II	1984-02-04
K840114	Coagulation Factor Deficient Plasma	Medical Specialties Laboratories	GGP	Class II	1984-02-04
K840109	Elecath Heparin Coated Temp. Pacing	Electro-Catheter Corp.	LDF	Class II	1984-02-04
K840102	Arterial Blood Gas Interpretation Prog	M. D. Software, Inc.	CCE	Class II	1984-02-04
K840059	Silitek Urinary Diversion Stent	Surgitek	FAD	Class II	1984-02-04
K840057	Exp* 500 Parallel Plate Dialyzer	Extracorporeal Medical Specialities, Inc.	KOC	Class II	1984-02-04
K840047	Lifepak 7D	Physio Control, Inc.	DRO	Class II	1984-02-04
K840027	Operating Room Stand	Healthmate, Inc.	FSE	Class I	1984-02-04
K840022	Heart Catheterization Tray Set	Medi-Plast Intl., Inc.	DRE	Class II	1984-02-04
K840017	Vertex Percutaneous Catheter Introduc	Professional Medical Services	DRE	Class II	1984-02-04
K840011	Resolve-Hb	Isolab, Inc.	GKA	Class II	1984-02-04
K834599	Autotechnicon V Tissue Process Sys	Technicon Instruments Corp.	IEO	Class I	1984-02-04
K834596	Blood Tubing	Renal Systems, Inc.	KOC	Class II	1984-02-04
K834591	Stopex-Condoms-	Tropex Worldwide, Inc.	HIS	Class II	1984-02-04
K834589	Biospal (R) 1800S	Hospal Medical Corp.	KDI	Class II	1984-02-04
K834579	Biospal 2400S	Hospal Medical Corp.	KDT	Class I	1984-02-04
K834575	Bard Karaya Gum Washers	C.R. Bard Inc	EXB	Class I	1984-02-04
K834571	Fibrinogen Test	Diatech, Inc.	KQJ	Class II	1984-02-04