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 1912 of 3531

510(k) clearances, page 1912 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K964517	Linac Scalpel Floorstand	Surgical Navigation Technologies, Inc.	IYE	Class II	1997-04-01
K964107	Oscor Permanent Retractable Screw-in Pacing Lead Model Pr	Oscor Medical Corp.	DTB	Class III	1997-04-01
K964074	Diolite 532	Iriderm Div.	GEX	Class II	1997-04-01
K963428	Umbilical Clamp and Cutter	R.O.S.T. Medical Development, Inc.	HFW	Class II	1997-04-01
K961156	Once-a-Day Bowie and Dick Test Pack.	Propper Mfg Co Inc	JOJ	Class II	1997-04-01
K954730	Benchmark Transfer Test	P.K. Morgan, Ltd.	BZC	Class II	1997-04-01
K954547	Ch-502A & Ch520b Digital Finger Sphygmomanometer	Citizen Watch Co., Ltd.	DXN	Class II	1997-04-01
K952683	Apex Medical Corp. Portable Interferential Stimulation Device	Wholesale Medical Imports, Inc.	LIH	Class II	1997-04-01
K970744	Style Eyes Optics	Anti-Ray, Inc.	HQY	Class I	1997-03-31
K970722	Eye Tray	Trinity Laboratories, Inc.	KKX	Class II	1997-03-31
K970594	Kalginate Impression Material	Teledyne Water Pik	ELW	Class II	1997-03-31
K970521	Trx Power Tilt and Recline System	Motion Concepts LP	ITI	Class II	1997-03-31
K970479	Minimed Sof-Serter Infusion Set Insertion System, Model 300	Medtronic, Inc.	KZH	Class II	1997-03-31
K970377	Plancon Microlamellar Keratome (Single Piece Keratome Head with Accessories)	Plancon Instruments	HNO	Class I	1997-03-31
K970349	Fuji Medical Laser Imager Mf Print Server Mf-Ps667	FUJIFILM Healthcare Americas Corporation	LLZ	Class II	1997-03-31
K970268	Alexander Manufacturing Company Prchargeable Battery	Alexander Mfg. Co.	MSG	Class II	1997-03-31
K970262	Multi-Channel Compression Bte (Sd)	Miracle-Ear, Inc.	ESD	Class I	1997-03-31
K970215	Audallion II Hearing System	Resound Corp.	ESD	Class I	1997-03-31
K965185	Acrypak Folder	Alcon Laboratories	KYB	Class I	1997-03-31
K964853	Intravia Container, Empty	Baxter Healthcare Corporation	KPE	Class II	1997-03-31
K964739	Steri-Oss Tiodized Screw	Steri-Oss, Inc.	DZE	Class II	1997-03-31
K964555	Vitrotec True Light Endoilluminator (100-S)	Vitrotec, Inc.	MPA	Class II	1997-03-31
K963983	E. Cam Profile Attenuation Correction	Siemens Corp.	KPS	Class II	1997-03-31
K963936	Accesspoint, Med E-Mail, Dicom Reader	Biosound, Inc.	LMB	Class I	1997-03-31
K963887	Pt-Pac Portable Heating Pad	Anthony A. Chiurco	IRT	Class II	1997-03-31
K963843	Electric Surgical Irrigation System - Dual Controller Unit	Micro Motors, Inc.	EFB	Class I	1997-03-31
K962370	Perfect Choice Prophy Paste with 10% Carbamide Peroxide	Challenge Products, Inc.	EJR	Class I	1997-03-31
K971057	Cogenlight Technologies Xls Illuminator System	Cogent Light Technologies, Inc.	GCT	Class II	1997-03-28
K970826	Selecta-Tip Laparoscopic Scissors	Microline Pentax, Inc.	GEI	Class II	1997-03-28
K970762	Dual Lumen Embolectomy Catheter	Applied Medical Resources Corp	DXE	Class II	1997-03-28
K970737	B-D Ultra-Fine II Short 31G X 5/16 Pen Needle	BD Becton Dickinson Vacutainer Systems Preanalytic	FMI	Class II	1997-03-28
K970565	Mammotome Biopsy Probe and Housing (Mammotome)	Biopsys Medical, Inc.	KNW	Class II	1997-03-28
K970541	Aesculap Modular Monopolar Electrodes	Aesculap Inc	GEI	Class II	1997-03-28
K970537	Rexton Model 48 and 49Pp	Rexton, Inc.	ESD	Class I	1997-03-28
K970244	Scimed Choice Family of Ptca Guide Wires	Scimed Life Systems, Inc.	DQX	Class II	1997-03-28
K970170	Swift Delivery Product #002-Vac Ex Cup W/vac Rel Valve	Richard G. Lindsay	HDB	Class II	1997-03-28
K970140	E0520-Trigger Switch and Cord/e0521-Trigger Switch	Medtronic, Inc.	GEI	Class II	1997-03-28
K970130	Hydrocool Dual Conductor Polymer Gel (30101-001/Corded Dispersive Electrode-Sensing	Medtrex, Inc.	GEI	Class II	1997-03-28
K970053	Ultratomerx	Boston Scientific Corporation	KNS	Class II	1997-03-28
K970046	Universal Low Profile Nasal Hoods(1250,1275,1350,1450,1475,1550)	Accutron Inc	KHA	Class I	1997-03-28
K970018	Fast Tract Transtracheal Procedure Kit	L.W. Ward and Assoc., Inc.	LRC	Class I	1997-03-28
K970005	Gyrex 2T-Prestige	Elscint, Inc.	LNI	Class II	1997-03-28
K965239	Pip Low Profile Scavenging System(260 and 261)/Universal Low Profile Scavenging System(260-U and 261-U)	Accutron Inc	CBN	Class II	1997-03-28
K965214	Coeur Front Load Injector Retrofit Kit (C859-0002)	Coeur Laboratories, Inc.	DTX	Class II	1997-03-28
K964971	Cryogen Cryosurgical System	Cryogen, Inc.	GEH	Class II	1997-03-28
K964441	Femrx Focused Monopolar (Fap) Operastar System [Outpatient Endoscopic Resection and Ablation (Opera)] [Specialized Tissu	Gynecare Innovation Center	KNF	Class II	1997-03-28
K964346	Paramax Triglycerid Reagent	Dade Intl., Inc.	CDT	Class I	1997-03-28
K963688	Focus Pv Balloon Dilatation Catheter	Cardiovascular Dynamics, Inc.	LIT	Class II	1997-03-28
K963293	Augustine Medical Wound Care System Model 68Xxx	Augustine Medical, Inc.	MSA	Class I	1997-03-28
K963262	Artoscan M	Biosound, Inc.	LNH	Class II	1997-03-28