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 2210 of 3531

510(k) clearances, page 2210 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K924101	Sterile Convertors Sms Polypropylene Gown & Drape	Baxter Healthcare Corporation	KKX	Class II	1994-04-11
K923259	Laparoscopy Sets, Needle Holders, Blunt Shears	Imtec Corp.	HET	Class II	1994-04-11
K922683	Prestyl Jet Injector	Bma Technologies S.A.	EJI	Class II	1994-04-11
K920083	Biochem Model 3302 Newox2 Oximeter	Biochem International, Inc.	DQA	Class II	1994-04-11
K940963	Xenon Light Source	Incredivision, Inc.	FFS	Class II	1994-04-08
K940962	Liquid Light 500	Incredivision, Inc.	FFS	Class II	1994-04-08
K936287	Kodak Surecell Hcg Urine Test, Modification	Eastman Kodak Company	JHI	Class II	1994-04-08
K936138	Kodak Surecell Hcg-Serum/urine Test Kit, Modification	Eastman Kodak Company	JHI	Class II	1994-04-08
K934209	Slt Reflecting Probe	Surgical Laser Technologies, Inc.	GEX	Class II	1994-04-08
K933537	Encompas Comfort Block # 0B-10	Encompas Unlimited, Inc.	MNK	Class I	1994-04-08
K925792	Exac-Temp & Clini-Temp Tympanic & Myocardial Probe	DeRoyal Industries, Inc.	FLL	Class II	1994-04-08
K941157	Basic Recline Chair	Labac Systems, Inc.	IOR	Class I	1994-04-07
K940800	Dentacolor Vita (Vs) Shade System	Kulzer GmbH	EBF	Class II	1994-04-07
K940407	Kaltogel Wound Dressing	Calgon Corp.	KMF	Class I	1994-04-07
K940398	Auto Suture Laparoscopic Fascia Closure Device II	United States Surgical, A Division of Tyco Healthc	GCJ	Class II	1994-04-07
K936193	Comb-18 Wound Dressing	Vsc Health Care Products	KMF	Class I	1994-04-07
K935225	Mitek Modular Drill Bit	Mitek Surgical Products, Inc.	GFG	Class I	1994-04-07
K935021	Handi-Foam	Medtec LLC	IYE	Class II	1994-04-07
K934685	Softtouch Guide Catheter	Mallinckrodt Medical	DQY	Class II	1994-04-07
K934373	Mobile Sophie Modification	Planmed Oy	IZH	Class II	1994-04-07
K933742	Top Gun	Bio-Medical Devices, Inc.	FQH	Class II	1994-04-07
K933460	Dvfx, Model M256	Xre Corp.	IZI	Class II	1994-04-07
K933362	Sharplan CO2 Surgical Laser	Laser Industries, Ltd.	GEX	Class II	1994-04-07
K933115	Digital Disk Recorder	Eigen	LMB	Class I	1994-04-07
K932128	Cmi E-Z Flo Bulb P.n. 701	Columbia Medical & Surgical, Inc.	FFY	Class I	1994-04-07
K931850	Verrss Pneumo Needle	Advanced Surgical, Inc.	GCJ	Class II	1994-04-07
K930573	Synvasive Ceramic Sutting Block	Synvasive Technology, Inc.	LXI	Class I	1994-04-07
K930473	Onecath L-Cath Catheter System	Luther Medical Products, Inc.	LJS	Class II	1994-04-07
K930320	Amo Phacoflex Inserter, Foldable IOL Insert Instr	Advanced Medical Optics, Inc.	KYB	Class I	1994-04-07
K926021	Needle Holders & Access for Lapar Surg-Ob/gyn Use	Zinnanti Surgical Instruments, Inc.	HET	Class II	1994-04-07
K925700	Zest Anchor Advanced Generation	Zest Anchors LLC	EGG	Class I	1994-04-07
K924985	Computerized Tomography X-Ray System Option	Siemens Medical Solutions USA, Inc.	JAK	Class II	1994-04-07
K911783	Allegro Viewing Wand	I.S.G. Technologies, Inc.	LLZ	Class II	1994-04-07
K941236	Vector Wheelchair	Vector Mobility, Inc.	IOR	Class I	1994-04-06
K940778	Sunglasses (Non-Prescription)	Hwa Meei Optical Co., Ltd.	HQY	Class I	1994-04-06
K940614	E.m.a.	European Manufacturers Agency, Inc.	HQZ	Class I	1994-04-06
K940560	Spectacle Frames	Optical Xpressions, Ltd.	HQZ	Class I	1994-04-06
K940549	Access(r) Human Luteinzing Hormone Assay	Bio-Rad Laboratories Inc.	CEP	Class I	1994-04-06
K940420	Talking Rap Shades	Hilco Corp.	HQY	Class I	1994-04-06
K940371	Surgical Sealant Applicator Tip Endoscopic Tip	Micromedics, Inc.	KYZ	Class I	1994-04-06
K940326	Spectacle Frame	D'Tochi, Inc.	HQZ	Class I	1994-04-06
K936198	Zeiss Superlux High-Intensity Light Sources	Carl Zeiss, Inc.	GCT	Class II	1994-04-06
K935974	Spectacle Frames and Sunglasses	Pan Oceanic Eyewear	HQY	Class I	1994-04-06
K935845	Spectacle Frames	New Star Corp.	HQZ	Class I	1994-04-06
K935795	Cedia Dau Thc Calibrators	Microgenics Corporation	DLJ	Class II	1994-04-06
K935734	Sunglasses	Esparkle International Co., Ltd.	HQY	Class I	1994-04-06
K935723	Splashmaster Face Protective Products (Tuffshield Faceshield, Vistaclear Faceshield)	Cabot Safety Corp.	LYU	Class I	1994-04-06
K935700	Jin Chang Sunglasses	Jin Chang Enterprise Co., Ltd.	HQY	Class I	1994-04-06
K935119	Radias 3Rd Generation Tsh Immunoassay	Bio-Rad	JLW	Class II	1994-04-06
K934919	The Signature Series, Magnum 100	Progressive Electrical Therapeutics	IPF	Class II	1994-04-06