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 2026-11-02, 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 2491 of 3531

510(k) clearances, page 2491 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K895513	Perry Sv-1 Hyperbaric Ventilator	Perry Baromedical Services	CBK	Class II	1990-12-19
K905099	Elegance Tsh Elisa	Bioclone Australia Pty, Ltd.	JLW	Class II	1990-12-18
K905009	Digitcare i.v. Start Kit	Digitcare Corp.	FOZ	Class II	1990-12-18
K904820	Microzyme T3 Enzyme Immunoassay Kit	IMMUNOTECH s.r.o.	CDP	Class II	1990-12-18
K904784	Cholestech L.d.x. Level 1 Control	Cholestech Corp.	JJY	Class I	1990-12-18
K904781	Cholestrech L.d.x (Tm) Level 2 Control	Cholestrech Corp.	JJY	Class I	1990-12-18
K904726	Lytening Tm 6/R	Amdev, Inc.	JFP	Class II	1990-12-18
K904682	Vistek Electronic Controller	Vistek Corp.	GEY	Class I	1990-12-18
K904681	Vls 5300 300W Xenon Light Source	Vistek Corp.	HBI	Class II	1990-12-18
K904657	Flowers Dorsal Columella Implant	Implantech Associates Inc	FZE	Class II	1990-12-18
K904656	Flowers Nasal Implant	Implantech Associates Inc	FZE	Class II	1990-12-18
K904609	Xenon Light Source	Medical Dynamics, Inc.	HBI	Class II	1990-12-18
K904407	Disposable Fiber Optic Delivery Syst/nd: Yag Surg	Fiber Delivery Concepts, Inc.	GEX	Class II	1990-12-18
K904318	Local Report Generator	Spacelabs, Inc.	DXN	Class II	1990-12-18
K904022	Nitro Blue Tetrazolium Reduction	Sigma Chemical Co.	GHD	Class I	1990-12-18
K903968	Toxo-Cube	Difco Laboratories, Inc.	LGD	Class II	1990-12-18
K903421	Topcon Ec-200 Endo-Photocoagulator Laser	Top Con	HQF	Class II	1990-12-18
K903162	Flexible Endoscopic Electrodes	North American Sterilization & Packaging Co.	FAS	Class II	1990-12-18
K903156	Control-Tip Cystoscopic Electrodes	North American Sterilization & Packaging Co.	FAS	Class II	1990-12-18
K905382	Scribbon	Varnum Corp.	JES	Class I	1990-12-17
K905221	Special Bond II	Ivoclar North America, Inc.	EBF	Class II	1990-12-17
K905220	Monobond S	Ivoclar North America, Inc.	EBF	Class II	1990-12-17
K905205	Dw 235	Ivoclar North America, Inc.	EJJ	Class II	1990-12-17
K905120	Saf Fixative	Microbiologics, Inc.	LIO	Class I	1990-12-17
K905078	Ortho Cmv-G Antibody Elisa Test	Ortho Diagnostic Systems, Inc.	LFZ	Class II	1990-12-17
K905077	Ortho Cmv-M Antibody Elisa Test	Ortho Diagnostic Systems, Inc.	LFZ	Class II	1990-12-17
K904959	Psg Hemostatic Control Valve	Peripheral Systems Group	DQO	Class II	1990-12-17
K904944	Transluminal Endarterectomy Device	Baxter Healthcare Corporation	DWX	Class II	1990-12-17
K904914	Dental Vacuum Injection Tray	The Lebanon Vac-Tray Corp.	KMT	Class I	1990-12-17
K904788	Mewissen Catheter	Boston Scientific Corporation	DQO	Class II	1990-12-17
K904787	Cri Steerable Catheter Control System	Catheter Research C/O Burditt, Bowles & Radzius	DXX	Class II	1990-12-17
K904742	Osada Endex	Osada Electric Co., Ltd.	LQY	Unclassified	1990-12-17
K904731	Qualitone Ite Genesis	Qualitone	ESD	Class I	1990-12-17
K904630	Centauri Yag Laser Syst, Ophthamology	Pfizer Laser Systems	GEX	Class II	1990-12-17
K904601	Advance Disposable Pressure Transducer	Advance Medical Designs Inc	DRS	Class II	1990-12-17
K904454	Hemochron(r) Prothrombin Time/modification	Accriva Diagnostics, Inc.	GJS	Class II	1990-12-17
K904390	Anti-Human Leu-2A (Cd8) Pe	BD Becton Dickinson Vacutainer Systems Preanalytic	GKZ	Class II	1990-12-17
K904389	Si-Pro	David F. Trungale	EYF	Class I	1990-12-17
K904331	L.p.i. Laser Delivery System	Laser Photonics, Inc.	GEX	Class II	1990-12-17
K904020	Memorymate Hearing Aid with Pmc Programmer	3M Company	ESD	Class I	1990-12-17
K903971	Argenco 26B	Argen Precious Metals, Inc.	EJS	Class II	1990-12-17
K903807	Cmv Igm Elisa Test	Gull Laboratories, Inc.	LFZ	Class II	1990-12-17
K903632	Intersept 1375 Venous Reservoir	Medtronic, Inc.	DTN	Class II	1990-12-17
K903539	Salter Labs Model #1015	Salter Labs	CBH	Class I	1990-12-17
K903491	Monitrode	Lleventon	DRX	Class II	1990-12-17
K903481	Alpha-Fill, Alpha-Cem, and Alpha-Silver	Dental Foremost	EBF	Class II	1990-12-17
K903284	Young Prophy System, Ps Unit	Young Dental Manufacturing Co 1, LLC.	KOJ	Class II	1990-12-17
K903208	Maxi-Flow Insufflator Tubing Set	Adler Instrument Company	HES	Class II	1990-12-17
K903199	Hollow Lumen Needle, Part Number: Mx920	Medex, Inc.	DQO	Class II	1990-12-17
K903078	Hasson Stabilizing Access Cannula	Marlo Surgical Technology	HET	Class II	1990-12-17