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 1939 of 3531

510(k) clearances, page 1939 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K964568	Ozark 46	Gateway Alloys, Inc.	EJT	Class II	1996-12-06
K964567	El Dorado 75	Gateway Alloys, Inc.	EJT	Class II	1996-12-06
K964566	Ozark 20	Gateway Alloys, Inc.	EJT	Class II	1996-12-06
K964475	Clinical Blood Gas Mixtures	Oxarc, LLC	JIS	Class II	1996-12-06
K964421	Remel Meropenem 10Ug Susceptibility Disk	Remel Inc	JTN	Class II	1996-12-06
K964216	Starkey Tm-3, Tm-5 High Frequency Tinnitus Masker	Starkey Laboratories, Inc.	KLW	Class II	1996-12-06
K964040	Trubyte Soft Reline System	Dentsply Intl.	EBI	Class II	1996-12-06
K963922	Alpha-Dent Root Canal Sealer & Filler	Wallace A. Erickson & Co.	KIF	Class II	1996-12-06
K963878	Ahs Omega HF	Authorized Hearing Systems, Inc.	ESD	Class I	1996-12-06
K963877	Ahs Omega Concept	Authorized Hearing Systems, Inc.	ESD	Class I	1996-12-06
K963743	Manan Prostate Uni-Lock	Argon Medical Devices, Inc	IWJ	Class I	1996-12-06
K963624	Philips Sli Series Linear Accelerator	Philips North America LLC	IYE	Class II	1996-12-06
K963276	The Safety 1St Digital Pacifier	Safety 1st, Inc.	FLL	Class II	1996-12-06
K962969	Medical Device Technologies, Inc.ultra	Medical Device Technologies, Inc.	KNW	Class II	1996-12-06
K962256	Galileo Hysteroscopes and Laparoscopes	Galileo Electro-Optics Corp.	HIH	Class II	1996-12-06
K961607	Virapump II (Models and Model M)	Viatro, Corp.	FEB	Class II	1996-12-06
K955073	Ksea Thermoflator (Model 26 4320 20)	Karl Storz Endoscopy-America, Inc.	HIF	Class II	1996-12-06
K950259	Coupling Device for Dental Prosthesis	Dr. Joseph E. Grasso, D.D.S.	EGG	Class I	1996-12-06
K964243	Humerus Wires	Compagnie Financiere & Medicale (Cf&M)	HSB	Class II	1996-12-05
K964175	Valleylab E2750 Laparoscopic Handset, Valleylab E2770 Series Electrodes	Medtronic, Inc.	GEI	Class II	1996-12-05
K964102	Tenet Tibial Fracture Support	Tenet Medical Engineering	GBB	Class I	1996-12-05
K963958	Impress, Perfecta, Acu-Form, and Acufit	Beltone Electronics Corp.	ESD	Class I	1996-12-05
K963770	Biocircuits Ios Quantitative Hcg Test Cartridges/biocircuits Ios Immunoassay Controls	Biocircuits Corp.	JJY	Class I	1996-12-05
K963128	Novagel Silicone Gel Sheeting	Brennen Medical, Inc.	MDA	Class I	1996-12-05
K962557	Genesis II Zirconium Femoral Component/profix Zirconium Femoral Component	Smith & Nephew Richards, Inc.	JWH	Class II	1996-12-05
K962276	Hemagen Ena Dsdna Kit (Eia Method)	Hemagen Diagnostics, Inc.	DHN	Class II	1996-12-05
K962203	Whisper Swivel II Exhalation Port	Respironics, Inc.	BZD	Class II	1996-12-05
K961633	Cd Horizon Spinal System	Sofamor Danek USA,Inc.	KWP	Class II	1996-12-05
K961530	Gish Reliance Oxygenator (Model Hfo)	Gish Biomedical, Inc.	DTZ	Class II	1996-12-05
K960389	Hyperbaric Chamber	Tampa Hyperbaric Ent.	CBF	Class II	1996-12-05
K935778	Via 1-01 Infusion Pump/blood Chemistry System	Via Medical Corp.	CCE	Class II	1996-12-05
K964476	De Oro 77	Gateway Alloys, Inc.	EJT	Class II	1996-12-04
K964121	Wallstent Tracheobronchial Endoprosthesis	Boston Scientific Corporation	JCT	Class II	1996-12-04
K964035	Phonak Microlink, Personal Fm Receiver	Phonak, Inc.	ESD	Class I	1996-12-04
K963811	Card Guard Model Cg-6106 Personal Electrocardiogram (ECG) Transmitter Device	Card Guard Scientific Survival, Ltd.	DXH	Class II	1996-12-04
K963736	Soft Denture Rebasing Resin	Sybron Dental Specialties, Inc.	EBI	Class II	1996-12-04
K963709	Cement-on Femoral Stem	Zimmer GmbH	JWH	Class II	1996-12-04
K963621	Stethos	Theratechnologies Inc.	DQD	Class II	1996-12-04
K963596	Polar Care 300	Breg, Inc.	ILO	Class II	1996-12-04
K963558	Cpi Model 6260, 6260A or 6261 Oil-Less Aspirator	Contemporary Products, Inc.	JCX	Class II	1996-12-04
K963328	Ams Ambicor Penile Prosthesis	American Medical Systems, Inc.	FAE	Class II	1996-12-04
K963231	Excel Onestep Urine Hcg Module Pregnancy Test	Excel Scientific, Inc.	JHI	Class II	1996-12-04
K962591	Foot Weight Alarm	Cleveland Medical Devices, Inc.	IRN	Class II	1996-12-04
K952315	Satmaster, Computerized Pulse Oximetry Software	Emg Scientific	DQA	Class II	1996-12-04
K950550	Xh-1 Neuromuscular Stimulator	California Medical Research Institute	IPF	Class II	1996-12-04
K964578	Fibrekor	Jeneric/Pentron, Inc.	EBF	Class II	1996-12-03
K963493	Ferritin Calibrator	Dade Chemistry Systems, Inc.	JIT	Class II	1996-12-03
K963320	Tfx Medical Guidewire	Tfx Medical Group	DQX	Class II	1996-12-03
K960970	Possis Angiojet Rapid Thrombectomy Catheter System, F105 Catheter,model 3030C,lf140 Catheter,model 3040C,pump Set 3020P	Possis Medical, Inc.	MCW	Class II	1996-12-03
K964477	Ozark 40	Gateway Alloys, Inc.	EJT	Class II	1996-12-02