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 1524 of 3531

510(k) clearances, page 1524 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K012193	Amc Antimicrobial Pin/wire Sleeve	Smith & Nephew, Inc.	JEC	Class II	2002-07-11
K021903	Kodak X-Omat Cassette/leadless for Dental Use	Eastman Kodak Company	IXA	Class II	2002-07-10
K021899	Concentric Balloon Guide Catheter, Model 90072	Concentric Medical, Inc.	DQY	Class II	2002-07-10
K021601	Michealth Et 1100/Et 1200 Infared Ear Thermometer	Duteck Industrial Co., Ltd.	FLL	Class II	2002-07-10
K020668	Aloka Ssd-1000 Diagnostic Ultrasound System, Models Asu-1003, Ust-9121, Ust-9124	Aloka Co., Ltd.	IYO	Class II	2002-07-10
K022050	Cgs-31A Multislice Upgrade Kit for Aquilion CT Scanner. Tsx-101A (Aquilion Advance Multi)	Toshiba America Medical Systems, In.C	JAK	Class II	2002-07-09
K021914	Microplex Coil Systems (Mcs)	Terumo Cardiovascular Systems Corporation	HCG	Class II	2002-07-09
K021908	Proven Modular Posterior Stabilized Femoral	Globus Medical, Inc.	JWH	Class II	2002-07-09
K021901	Wallgraft Tracheobronchial Endoprothesis with Unistep Plus Delivery System	Boston Scientific Corporation	JCT	Class II	2002-07-09
K021497	Cypress Ultrasound System	Acuson Corp.	IYN	Class II	2002-07-09
K021473	Bair Hugger Temperature Management System	Augustine Medical, Inc.	DWJ	Class II	2002-07-09
K021394	Diamedix Is-Rheumatoid Factor Test System	Diamedix Corp.	DHR	Class II	2002-07-09
K021207	Starlight	Orthomerica Products, Inc.	OAN	Class II	2002-07-09
K021170	Tsrh Spinal System	Medtronic Sofamor Danek USA Inc	KWP	Class II	2002-07-09
K021149	Aurora Ds	Syneron Medical, Ltd.	GEX	Class II	2002-07-09
K020527	Horizon Phacoemulsification System, Model Hzn-2030	Tenex Health	HQC	Class II	2002-07-09
K020456	Easi 12 Lead Algorithm	Philips North America LLC	DRW	Class II	2002-07-09
K014297	Endovive Initial Placement Gastrostomy Kit; Endovive Low Profile Button Replacement Gastrostomy Tube; Securi-T Initial P	Boston Scientific Corporation	KNT	Class II	2002-07-09
K013634	Bioteque 3 in 1 Hemodialysis Blood Tubing Pack	Bioteque Corp.	FJK	Class II	2002-07-09
K013434	Vp-2000/1000	Colin Corp.	DXN	Class II	2002-07-09
K013418	Am-Bio Extended Range Series Dialyzer, Models Wet and Dry	Asahi Kasei Medical MT Corp. Oita Works	KDI	Class II	2002-07-09
K021488	Surecan Safety Huber Needle Infusion Sets	B.Braun Medical, Inc.	FPA	Class II	2002-07-08
K013909	S7 Elite Cp Ap System	ResMed Corp	BZD	Class II	2002-07-08
K022018	Rhigene Ana Elisa Test System, Model K7560	Rhigene, Inc.	LJM	Class II	2002-07-05
K021730	Glovco Brand Powder-Free Nitrile Examination Gloves (Purple)	Glovco (M) Sdn. Bhd.	LZA	Class I	2002-07-05
K021428	Clinitek Atlas Pro 12 Reagent Pak System	Bayer Corp.	JFY	Class II	2002-07-05
K021358	Embryo Biopsy Medium	FUJIFILM Biosciences Inc.	MQL	Class II	2002-07-05
K021253	Ultrasonic Tips with Diamond Coating	Sybron Endo/Analytic	ELC	Class II	2002-07-05
K021179	Disposable Guidewire, Models G-205-3545S & G-205-3545A	Olympus Optical Co., Ltd.	OCY	Class II	2002-07-05
K021119	Powdered Brown Latex Surgical Gloves, Sterile with Expiration Date Labeling Claim & Protein Content Labeling Claim	WRP Asia Pacific Sdn Bhd	KGO	Class I	2002-07-05
K021007	Ultra Preserve with Aloe Vera (Green) Natural Rubber Latex Examination Glove Made from Allotex an Enzyme Treated Natural	Tillotson Healthcare Corp.	LYY	Class I	2002-07-05
K020818	Powder-Free Latex Examination Gloves with Colorants	Medtronic, Inc.	LYY	Class I	2002-07-05
K020475	Chad Therapeutics Oxypenumatic Cypress Model 511	Chad Therapeutics, Inc.	NFB	Class II	2002-07-05
K021958	Trellis Plus Infusion System (140Cm Catheter Length 10Cm Infusion Length 20Cm (100Cm Catheter Length 10Cm Infusion H	Bacchus Vascular, Inc.	QEY	Class II	2002-07-03
K021919	Scs Claris Spinal System,rextended Omniaxial Connector-,Medium, Model Co05, Scs Claris Spinal System,extended Omniaxialo	Ortho Tec, LLC	KWP	Class II	2002-07-03
K021827	Modification to Accu-Chek Active System	Roche Diagnostics GmbH	NBW	Class II	2002-07-03
K021453	Heartstream Xl Defibrillator/monitor, Model #M4735a	Philips North America LLC	MKJ	Class III	2002-07-03
K021407	Coalescent Surgical U-Clip - or Other Tbd and Accessories	Coalescent Surgical	FZP	Class II	2002-07-03
K021366	Mac-Lab/cardiolab Ep/combolab	General Electric Medical Systems Information Techn	DQK	Class II	2002-07-03
K021337	Aart Pectoralis Implant	Aesthetic and Reconstructive Technologies, Inc.	MIC	Class II	2002-07-03
K021332	Wiener Lab. Ck-Nac UV Unitest, Wiener Lab. Ck-Nac UV Aa, Wiener Lab. Ck-Nac UV Aa, Wiener Lab.nac UV Aa Liquida	Wiener Laboratories Saic	CGS	Class II	2002-07-03
K021261	Seednet System and Seednetgold System, Models Gp6t5, Gp5t5, Gp5t3, Hp5t5 & Hp5t3	Galil Medical Ltd.	GEH	Class II	2002-07-03
K021159	Powdered Latex Surgiacal Gloves, Steerile with Expiration Date Labeling Claim	WRP Asia Pacific Sdn Bhd	KGO	Class I	2002-07-03
K021094	Introcan Safety IV Catheter	B.Braun Medical, Inc.	DYB	Class II	2002-07-03
K021084	Light Saber Spinal Needle	Minrad, Inc.	FMF	Class II	2002-07-03
K020852	Poly-Chem Glucose	Polymedco, Inc.,/Polymedco Cancer Diagnostic Products, LLC	CFR	Class II	2002-07-03
K020484	Careside Ldh	Careside, Inc.	CFH	Class II	2002-07-03
K020431	Fibiocore	Est. Anthogyr	ELR	Class I	2002-07-03
K013768	Powered Muscle Stimulator	Theratech, Inc.	IPF	Class II	2002-07-03
K012622	Clearmedical/nellcor Oxisensor II, Pediatric, Model D-20	Clearmedical, Inc.	NLF	Class II	2002-07-03