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 2394 of 3531

510(k) clearances, page 2394 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K915282	Hemagen Ena Scl-70 Kit (Eia Method)	Hemagen Diagnostics, Inc.	LLL	Class II	1992-02-12
K915158	Surebreath Dome, E-Z Breather	Ipax, Inc.	GAD	Class I	1992-02-12
K914118	I.c. Medical Auto Intra-Abdominal Plume Eliminator	I.C. Medical, Inc.	FYD	Class II	1992-02-12
K913945	Stabilet Infant Radiant Warmer Model 2000C	Hill-Rom Inc.	FMT	Class II	1992-02-12
K913476	Gi Bleeder/od Set	Abbott Medical	KNT	Class II	1992-02-12
K913419	Regency, Compare, Sun Optics Sunglasses	Cliff Weil, Inc.	HQY	Class I	1992-02-12
K904509	Power Trainer with Neuromuscular Stimulation	Sinties Scientific, Inc.	IPF	Class II	1992-02-12
K920391	Voyageur and Laurentian Series Wheelchair	Invacare GmbH	IOR	Class I	1992-02-11
K920380	Jace Model W550 Wrist Cpm Device	Jace Systems, Inc.	BXB	Class I	1992-02-11
K920252	Curad Kid Size Instant Cold Pack	Kendall Healthcare Products Co. Div.Of Tyco Health	IMD	Class I	1992-02-11
K920165	Sunglasses (Non-Prescription)	Blair Corporation	HQY	Class I	1992-02-11
K915836	Cordis 5.0 French Super Torque Catheters	Cordis US Corp.	DQO	Class II	1992-02-11
K915777	Cordis Shuttle Catheter	Cordis US Corp.	DQY	Class II	1992-02-11
K915768	Surgi Light Nd:yag Laser System Model 904030	Surgical Laser Products, Inc.	GEX	Class II	1992-02-11
K915638	Talley Tm200 Intermttent Compression Unit	Progressive Medical Technology, Inc.	IRP	Class II	1992-02-11
K915637	Talley Tm500 Sequential Multicom Compression Syst.	Progressive Medical Technology, Inc.	IRP	Class II	1992-02-11
K915609	Ultra R-11 Cruiser	Brookefield Hunter, Inc.	ITI	Class II	1992-02-11
K915349	Pta Balloon Catheter	Schneider Intl., Ltd.	LIT	Class II	1992-02-11
K915344	Hemochron Onestep Aptt Test	Accriva Diagnostics, Inc.	GFO	Class II	1992-02-11
K915297	Trocar & Trocar Sleeeve 11Mm, 10Mm, 8Mm & 5Mm	Lifeguard Medical Products, Inc.	HET	Class II	1992-02-11
K915228	Disposable CO2 Gas Sampling/oxygen Delivery Cannul	Hospitak, Inc.	CCK	Class II	1992-02-11
K915216	Solution System Cup	Depuy, Inc.	JDI	Class II	1992-02-11
K915140	Primary Dressing Tray	Mediflex Intl.	LYY	Class I	1992-02-11
K915132	Mck Maximum Congruent Knee) Knee System	Zimmer GmbH	JWH	Class II	1992-02-11
K915127	Med.exam.gloves Powdered Anatomically Correct	Hedd Roz Canada, Inc.	LYY	Class I	1992-02-11
K915126	Latex Med.exam.gloves Powdered Ambidextrous	Hedd Roz Canada, Inc.	LYY	Class I	1992-02-11
K915124	Universal Compresion Screw	Howmedica Corp.	HWC	Class II	1992-02-11
K915114	Guide Wire Extension	Target Therapeutics	DQX	Class II	1992-02-11
K915107	Keith a-Gaurd	Kbk Medical Products, Inc.	LYY	Class I	1992-02-11
K915092	Talley Tm300 Sequential Multicom Compression Syst	Progressive Medical Technology, Inc.	IRP	Class II	1992-02-11
K915065	I.v.irrigation Pole	American Medical Mfg., Inc.	FOZ	Class II	1992-02-11
K914774	Multipulse Sequential Compression Unit	Talley Group Ltd.	IRP	Class II	1992-02-11
K914550	Antinuclear Antibody Immunoglobulin Test System	Diagnostic Resources, Inc.	LKJ	Class II	1992-02-11
K914234	Saunette, Portable Steam Cabin	Sauna Magic, Inc.	IMB	Class II	1992-02-11
K914032	Nitinol Seeker(r) Guide Wires	Target Therapeutics	DQX	Class II	1992-02-11
K914031	Guider-22	Target Therapeutics	DQX	Class II	1992-02-11
K914030	Guider, Dasher	Target Therapeutics	DQX	Class II	1992-02-11
K913804	Excelsior Single Lead Dispensing Set	Excel Medical, Inc.	LHI	Class II	1992-02-11
K913686	Sunshades, Acrylic Lenses, Silver Coated #Hx-602	Tel-Time Products	HQY	Class I	1992-02-11
K913337	Injection Cap	Cp Medical	FPA	Class II	1992-02-11
K912822	Personal Body Massager, Models 1605 & 1606	Raymond Industrial, Ltd.	ISA	Class I	1992-02-11
K912464	Permanent Cardiac Pacing Leads and Adaptors	Medtronic, Inc.	DTB	Class III	1992-02-11
K912059	Pre-Angled Abutments	Core-Vent Corp.	DZE	Class II	1992-02-11
K903999	Obutment Hb	O Co., Inc.	DZE	Class II	1992-02-11
K903663	Medscope 8Mm and 10Mm Laparoscope	Medscope Corp.	HET	Class II	1992-02-11
K915652	Nicolet Poratble Spirit System	Nicolet Instrument Corp.	GWF	Class II	1992-02-07
K915370	Copper Vapor Laser System	Metatech Corp.	GEX	Class II	1992-02-07
K915364	Chronocor VI Model 5012	Seamed Corp.	DTE	Class II	1992-02-07
K915259	Fx-Cablelok System, Modification	Biodynamic Technologies, Inc.	JDQ	Class II	1992-02-07
K915224	Cardiophonics Memory Transmitter	Rlt Medical Assoc., Inc.	DXH	Class II	1992-02-07