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 2310 of 3531

510(k) clearances, page 2310 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K930119	Coulter Retic-C Cell Control	Coulter Electronics, Inc.	JPK	Class II	1993-04-05
K930055	Antimicrobial Susceptibility Test Panel	Alamar Biosciences Laboratory, Inc.	JWY	Class II	1993-04-05
K926104	Polyp Net	United States Endoscopy Group, Inc.	GCJ	Class II	1993-04-05
K924790	Burton Auto Refractor - Model Bar-7	R.H. Burton Co.	HKO	Class I	1993-04-05
K924788	Burton Lensmeter	R.H. Burton Co.	HLM	Class I	1993-04-05
K924785	Burton Radiusgauge - Model 2030	R.H. Burton Co.	HLM	Class I	1993-04-05
K924784	Burton Projector Head - Model 6000-H	R.H. Burton Co.	HOS	Class I	1993-04-05
K924780	Burton Ophthalmic Exam Unit - Model 2201	R.H. Burton Co.	HMF	Class I	1993-04-05
K924779	Burton Keratometer - Modle 2040	R.H. Burton Co.	HJB	Class I	1993-04-05
K924778	Burton Auto Refractor/keratometer - Model Bark-8	R.H. Burton Co.	HKO	Class I	1993-04-05
K924777	Burton Applanation Tonometer - Model T850 & T1000	R.H. Burton Co.	HKX	Class II	1993-04-05
K924776	Burton Lensmeter - Model 2021	R.H. Burton Co.	HLM	Class I	1993-04-05
K924771	Burton Ophthalmic Stand - Model Xl3200	R.H. Burton Co.	HMF	Class I	1993-04-05
K924760	Tomey Proton Tonometer	Tomey Corporation USA	HKY	Class II	1993-04-05
K924524	Force Gsu(tm) Handset W/3 & 6 Flexible Extender	Medtronic, Inc.	GEI	Class II	1993-04-05
K923876	Riskontrol Single Use	Riskontrol	ECB	Class I	1993-04-05
K923313	Roche Oxi/ferm II	Roche Diagnostic Systems, Inc.	LQM	Class I	1993-04-05
K923274	Zeiss Visulas Diode Laser	Carl Zeiss, Inc.	GEX	Class II	1993-04-05
K922685	Trocars	Endoscopic Technologies, Inc.	GCJ	Class II	1993-04-05
K920595	Endopath Interceed Absorbable Adhesion Barrier	Ethicon, Inc	GCJ	Class II	1993-04-05
K911729	Danekscope and Accessories	Danek Medical, Inc.	HRX	Class II	1993-04-05
K924191	Tracheostomy Care Set with Gloves and Extra Towel	American Healthcare Corp.	BTO	Class II	1993-04-02
K924096	Cmv Elisa Test System	Zeus Scientific LLC	LFZ	Class II	1993-04-02
K921400	Hip Joint Prothesis	Smith & Nephew Richards, Inc.	LPH	Class II	1993-04-02
K924018	M3 Lag Screw Fixation System	Osteomed	HWC	Class II	1993-04-01
K922210	Hewlett-Packard Model 78730 Carevue 5000	Hewlett-Packard Co.	MHX	Class II	1993-04-01
K930762	Superstar	Jelenko Co.	EJT	Class II	1993-03-31
K930601	Freedom	J.F. Jelenko & Co., Inc.	EJT	Class II	1993-03-31
K930490	Slt Multidimensional Contact Laser Syst A4060c	Surgical Laser Technologies, Inc.	GEX	Class II	1993-03-31
K930482	Dental Casting Alloy, Modification - Pf-3	Deringer-Ney, Inc.	EJT	Class II	1993-03-31
K930481	Dental Casting Alloy Modification-Pf-4	Deringer-Ney, Inc.	EJT	Class II	1993-03-31
K930413	Premier Classic	Everest & Jennings, Inc.	IOR	Class I	1993-03-31
K930412	Premier 2 Wheelchair	Everest & Jennings, Inc.	IOR	Class I	1993-03-31
K930411	Universal Wheelchair	Everest & Jennings, Inc.	IOR	Class I	1993-03-31
K926578	Uni-Stick Plastic Ligature, Modified	American Orthodontics	ECI	Class I	1993-03-31
K926458	Bifix Dental Cement	Voco GmbH	EMA	Class II	1993-03-31
K926419	Calcicur	Voco GmbH	EJK	Class II	1993-03-31
K926418	Clip	Voco GmbH	EBF	Class II	1993-03-31
K926411	Saf-Lift/saf-Kary	Arjo-Century, Inc.	FNG	Class II	1993-03-31
K926407	Model Cole Tab-2 Table W/model Cole Sfd-2 Spotfilm	Nucletron-Oldelft Corp.	KXJ	Class II	1993-03-31
K926406	Dual Cure Reline Material	Dentsply Intl.	EBI	Class II	1993-03-31
K926238	Bisco Porcelain Etching Gel	Bisco, Inc.	EIH	Class II	1993-03-31
K926170	Stepmill Exercise System	Stairmaster Sports/Medical Products, Inc.	ISD	Class II	1993-03-31
K926120	Contour Femoral Hip Stem with Porocoat	Depuy, Inc.	KWL	Class II	1993-03-31
K926047	Ace 8.0Mm Cannulated Cancellous Bone Screw	Ace Orthopedic Manufacturing Co.	HWC	Class II	1993-03-31
K925977	Paramed Flexion-Extension Machine	Paramed Services, Inc.	BXB	Class I	1993-03-31
K925974	Casting Gold,ceramic,gold Wire,alloy Precision Att	Metalor Dental USA Corp.	EJT	Class II	1993-03-31
K925973	Vs1 Gpf, Vacu Pf	Metalor Dental USA Corp.	EJT	Class II	1993-03-31
K925618	3M Remover Lotion Product Number 86Xx	3M Company	KOX	Class I	1993-03-31
K925271	Repex-Repeated Endrange Passive Exercise Machine	Repex Intl., Inc.	BXB	Class I	1993-03-31