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 1938 of 3531

510(k) clearances, page 1938 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K963746	Ids Dental Floss with Sodium Fluoride Microdent Dental Floss with Sodium Fluoride Ap-24 Dental Floss with Sodium Fluorid	Whitehill Oral Technologies, Inc.	JES	Class I	1996-12-12
K963728	The Special Electromagnetic Therapeutic Apparatus	China Chongqing Bashan Instrument Factory	ILY	Class II	1996-12-12
K963691	Courier Balloon Dilatation Catheter	Boston Scientific Corporation	FGE	Class II	1996-12-12
K963689	Recover Adult Vein Warmer	Florida Medical Industries, Inc.	IMD	Class I	1996-12-12
K963679	Loving Smarter - Safer Sex	Loving Smarter, Inc.	HIS	Class II	1996-12-12
K963669	Grass Model 15 Neurodata Amplifier System	Astro-Med, Inc.	GWL	Class II	1996-12-12
K962612	Bilibed Phototherapy Lamp	Medela AG	LBI	Class II	1996-12-12
K962528	Olympus Mobile Chair/couch	KEYMED (Medical & Industrial Equipment) Ltd	FZK	Class I	1996-12-12
K962447	Equinox Digital EEG System	Physiometrix, Inc.	GWQ	Class II	1996-12-12
K964469	700-F Series Stimulation Electrodes	Cardiotronics Systems, Inc.	LDD	Class II	1996-12-11
K963159	Conductive Hydrogel Polymer Based on U & C Series Electrodes	Cmc Sense-It, Inc.	DRX	Class II	1996-12-11
K962855	Ule-2, Mule-2, Hand Accessory Kit	Penny and Giles Biometrics, Ltd.	ISD	Class II	1996-12-11
K950719	Oes Urology	OLYMPUS Corporation of the Americas	EZO	Class II	1996-12-11
K964775	Ardent Futura Non Gamma-2	Ardent Production Development	EJJ	Class II	1996-12-10
K963924	Lc Star Reusable Nebulizer 22F50 and Lc Star Disposable Nebulizer 22F70	Pari Holding Co.	CAF	Class II	1996-12-10
K963852	Ksea Thermocoagulator (Model 265100 20)	Karl Storz Endoscopy-America, Inc.	HGI	Class II	1996-12-10
K963835	Digoxin Enzyme Immunoassay	Diagnostic Reagents, Inc.	KXT	Class II	1996-12-10
K963692	Verdict Pcp	Editek, Inc.	LCM	Unclassified	1996-12-10
K962915	Actis (Venous Flow Controller)	Vivus, Inc.	LKY	Class II	1996-12-10
K962734	Cedia Dau Benzodiazepine Assay	Boehringer Mannheim Corp.	JXM	Class II	1996-12-10
K962625	Vitajet	Vitajet Corp.	KZE	Class II	1996-12-10
K962598	Nichols Advantage Chemiluminescence Intact Parathyroid Hormone Kit	Nichols Institute Diagnostics	CEW	Class II	1996-12-10
K961984	Porphobilinogen (Pbg)	Trace America, Inc.	JNF	Class I	1996-12-10
K961908	Thor Henostatsis Analyzer Cat. No. 1450, 1451	Helena Laboratories, Corp.	JPA	Class II	1996-12-10
K961223	Multiple Parameter Telemetry, Vital View, & Microview Systems	Criticare Systems, Inc.	LOS		1996-12-10
K961138	Esort II + 400 Series Monitor	Medical Data Electronics	DRO	Class II	1996-12-10
K960771	Slav and Slav-One Injection Port Connector System	RyMed Technologies, LLC	FPA	Class II	1996-12-10
K960734	Haemocell System 350 or S350	Haemocell PLC	CAC	Class II	1996-12-10
K955031	Maxistim	Life-Tech Intl., Inc.	KOI	Class II	1996-12-10
K954523	Thermoscan Instant Thermometer Model Ir-6000	Thermoscan, Inc.	FLL	Class II	1996-12-10
K954505	Ez Stim	Life-Tech Intl., Inc.	KOI	Class II	1996-12-10
K965256	Dms-1000C Dermoabrader	Mattioli Engineering Corp.	GFD	Class I	1996-12-09
K964500	Acumed Tension Band Pin	Acu Med, Inc.	HTY	Class II	1996-12-09
K964458	Ellis External Mini-Fixator System	Link America, Inc.	KTT	Class II	1996-12-09
K964334	Expandacell Anti-Fog Instrument Wipe (with Alcohol)/(without)	Summit Medical, LLC	GCJ	Class II	1996-12-09
K963956	Portable Liquid Oxygen Unit and Stationary Liquid Oxygen Unit	Southern Research, Inc.	BYJ	Class II	1996-12-09
K963885	Ultima Fx Femoral Hip Stems	Johnson & Johnson Professionals, Inc.	KWY	Class II	1996-12-09
K963796	Kinemax Plus Modular Stabilizer Femoral Component and Femoral Spacers	Howmedica Corp.	JWH	Class II	1996-12-09
K963204	Dms-1000C Dermoabrader	Aesthetic Lasers, Inc.	GFE	Class I	1996-12-09
K962880	Sensi-Touch Combo Spinal/epidural Regional Anesthesia Delivery System	Sherwood Medical Co.	CAZ	Class II	1996-12-09
K962661	Ml Microkeratome Blade	Med-logics Inc	HNO	Class I	1996-12-09
K962608	Synthes (u.s.a.) Universal Spinal Parallel Connector	Synthes (USA) Products LLC	MNH	Class II	1996-12-09
K962314	Halifax Plus Interlaminar Clamp System	Osteonics Corp.	KWP	Class II	1996-12-09
K961937	Simulscope Auscultation and Simulscope Bedside Auscultation System	Delphi Consulting Group	DQD	Class II	1996-12-09
K961643	Medicotest ECG Electrodes	Medicotest, Inc.	DRX	Class II	1996-12-09
K953990	Transflow Test	P.K. Morgan, Ltd.	BZC	Class II	1996-12-09
K964603	Articular Hearing Aids	Decibel Instruments, Inc.	ESD	Class I	1996-12-06
K964573	Piedmont 70 (Ch-35)	Gateway Alloys, Inc.	EJT	Class II	1996-12-06
K964572	Palladia 76	Gateway Alloys, Inc.	EJT	Class II	1996-12-06
K964569	El Dorado 58	Gateway Alloys, Inc.	EJT	Class II	1996-12-06