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 2083 of 3531

510(k) clearances, page 2083 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K945484	Pidural Steroid System	Professional Medical Device Consultants	CAZ	Class II	1995-06-02
K944717	W&h 798 Top Air Turbine Triple Spray	A-dec, Inc.	EFB	Class I	1995-06-02
K944716	W&h 796 Top Air Turbine Mini-Head	A-dec, Inc.	EFB	Class I	1995-06-02
K944715	W&h 795 Top Air Turbine Single Spray	A-dec, Inc.	EFB	Class I	1995-06-02
K944710	W&h 898 Top Light Highspeed	A-dec, Inc.	EFB	Class I	1995-06-02
K944708	W&h 895 Top Ligh Highspeed Fiberoptic Single Spray	A-dec, Inc.	EFB	Class I	1995-06-02
K944495	Model 3200 Vascular Mini-Lab	Parks Medical Electronics Inc	MHX	Class II	1995-06-02
K944287	7050 Ultrasound Imaging System	Biosound, Inc.	ITX	Class II	1995-06-02
K943934	Aortic Arch Cannulas	Corcym Inc.	DWF	Class II	1995-06-02
K943358	Naviguide Hydrophilic Guide Wire	Meadox Medicals, Div. Boston Scientific Corp.	DQX	Class II	1995-06-02
K942170	Model 511 Infant Monitor	GE Medical Systems Information Technologies, Inc.	BZQ	Class II	1995-06-02
K941923	Sterile Treatment Electrode	Staodyne, Inc.	GZJ	Class II	1995-06-02
K933683	Pentax Face Mask	Pentax Precision Instrument Corp.	FXX	Class II	1995-06-02
K933197	The Signature Series, M IV	Progressive Electrical Therapeutics	GZJ	Class II	1995-06-02
K952391	Dynabite Urological Forceps	Portlyn Corp.	FCL	Class I	1995-06-01
K952301	Laser Gas Mixture	Airgas Management, Inc.	GEX	Class II	1995-06-01
K952162	Medical Mixture-Laser Gas Mixtures	Standard Welders Supply Co.	GEX	Class II	1995-06-01
K952113	Tbn-Tipped Optical Fiber	Myriad Lase, Inc.	GEX	Class II	1995-06-01
K952056	Immunoassay Drugs of Abuse Controls	Medi-Tech, Inc.	DIF	Class I	1995-06-01
K951966	Human Prealbumin Radial Immunodiffusion Kit	Kent Laboratories, Inc.	JZJ	Class I	1995-06-01
K951782	Stabilor G	Degussa AG	EJT	Class II	1995-06-01
K951780	Stabilor Nf IV	Degussa AG	EJT	Class II	1995-06-01
K951755	Emit 2000 Digoxin Assay	Syva Co.	KXT	Class II	1995-06-01
K951441	Dupont Aca Digoxin (Dgn a) Method	E.I. Dupont de Nemours & Co., Inc.	KXT	Class II	1995-06-01
K951383	Tempra Heat Pack	Tempra Technology, Inc.	IMD	Class I	1995-06-01
K951382	Hlt 406	Health Care Mfg., Inc.	INQ	Class I	1995-06-01
K951319	Roche Abuscreen Online for Opiates 1000 Test Kit-2000 Ng/ml Cutoff Olympus Au800 Instrument Application	Roche Diagnostic Systems, Inc.	DOE	Class II	1995-06-01
K951204	Sharplan Model 712 Acuspot Micromanipulator	Sharplan Lasers, Inc.	GEX	Class II	1995-06-01
K951163	Gore Smoother Guided Rasp	W. L. Gore & Associates, Inc.	HRX	Class II	1995-06-01
K951058	Glucometer Encore Qa+ Blood Glucose Meter Workstation	Kulzer GmbH	CFR	Class II	1995-06-01
K950979	Hep-2000 Colorzyme Ana-Ro Test System	IMMUNO CONCEPTS, NA, Ltd.	DHN	Class II	1995-06-01
K950802	Linical Protein I Calibration Verifiers Levels a - for Beckman Array 360 System	International Enzymes, Inc.	JJY	Class I	1995-06-01
K950727	One Touch Profile Complete Diabetes Tracking System	Lifescan, Inc.	CGA	Class II	1995-06-01
K950592	Accessories Foe Orthopedic Surgical Procedures	Eare Consulting Service	HRX	Class II	1995-06-01
K945564	Model 550-Dc Crossfire(tm)	Eclipse, Inc.	GEX	Class II	1995-06-01
K945538	Staphaurex Plus(tm)	Murex Diagnostics Limitd	JWX	Class I	1995-06-01
K952053	E-Z Set, Saf-T E-Z Set, and Minicath Infusion Sets	Becton Dickinson Vascular Access, Inc.	FPA	Class II	1995-05-31
K952006	Accu-Beam Fiber Optic Handpiece	Tti Medical	GEX	Class II	1995-05-31
K951954	Cardon Physical Therapy Table Model R27108	Cardon Rehabilitation Products, Inc.	INQ	Class I	1995-05-31
K951953	Cardon Phsical Therapy Table Model R27630	Cardon Rehabilitation Products, Inc.	INQ	Class I	1995-05-31
K951952	Cardon Physical Therapy Table Model R27112	Cardon Rehabilitation Products, Inc.	INQ	Class I	1995-05-31
K951811	Osteotech Musculoskeletal Tissue Recovery Pack	Osteotech Inc	LRP	Class I	1995-05-31
K951778	Degudent U	Degussa AG	EJT	Class II	1995-05-31
K951777	Degustar Ga-2	Degussa AG	EJT	Class II	1995-05-31
K951733	Nexhat-Dorsey Pencil-Grip Trumpet Valve with Cutting and Coagulation Hand Controls	American Hydro-Surgical Instruments, Inc.	GCJ	Class II	1995-05-31
K951465	Sunlite 1275	Fen Dental Mfg., Inc.	EBZ	Class II	1995-05-31
K951270	Pulpdent Glass Ionomer Cements	Pulpdent Corporation	EMA	Class II	1995-05-31
K951089	Scimed Gateway Plus	Scimed Life Systems, Inc.	DTL	Class II	1995-05-31
K951084	S-Rom Opc (One-Piece Cemented) II Femoral Hip Prosthesis	Joint Medical Products Corp.	JDI	Class II	1995-05-31
K945752	Celsite(tm) Brachial Venous Port	B. Braun of America, Inc.	LJT	Class II	1995-05-31