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 1876 of 3531

510(k) clearances, page 1876 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K972099	Sharplan Epitouch Ruby Laser System	Sharplan Lasers, Inc.	GEX	Class II	1997-08-27
K972002	Cynosure Dermatology Laser Cooling Tip	Cynosure, LLC	GEX	Class II	1997-08-27
K971316	Poly (Vinyl) Exam Glove, Powdered	Copioumed Intl., Inc.	LYZ	Class I	1997-08-27
K971166	Optical Mediastinoscope with Plug-in Connection/ocular Eyepiece	Richard Wolf Medical Instruments Corp.	EWY	Class II	1997-08-27
K965244	Z Tech Transcutaneous Neural Stimulation	Z Technologies, LLC	GZJ	Class II	1997-08-27
K965237	Nurses Bouffant Cap	Copioumed Intl., Inc.	LYU	Class I	1997-08-27
K964779	Model I 100 RF Passive Attenuator/splitter and Model Ql 10 Loop Electrode	Quantum Loop, Inc.	GEI	Class II	1997-08-27
K973063	Frequency 55 (Methafilcon a) Hydrophilic Contact Lens for Daily Wear	Aspect Vision Care, Ltd.	LPL	Class II	1997-08-26
K972940	Aurecast Bio 69Pf	Aurex Precious Metal Industries (Pty)Ltd	EJT	Class II	1997-08-26
K972939	Aurecast Bio 59Pf	Aurex Precious Metal Industries (Pty)Ltd	EJT	Class II	1997-08-26
K972810	Opt80 the Transportable (Opt80)	O.P.T. USA, Inc.	FQO	Class I	1997-08-26
K972594	Metalprimer II	GC America Inc.	KLE	Class II	1997-08-26
K972508	Surgical Burs and Surgical Drill Bits	Synvasive Technology, Inc.	HWE	Class I	1997-08-26
K972503	Cardioplegia Adapters, Vessel Canulae, and Aortic Root Cannulae	Corcym Inc.	DWF	Class II	1997-08-26
K972444	3I Innovative Implants and Cover Screws	ZimVie US Corp LLC	DZE	Class II	1997-08-26
K972356	Innovasive 2.3Mm Roc Ez Suture Bone Fastener	Innovasive Devices, Inc.	MBI	Class II	1997-08-26
K972319	Aurecast Gf	Aurex Precious Metal Industries (Pty)Ltd	EJT	Class II	1997-08-26
K972240	Imtec Biobarrier Membrane	Imtec Corp.	NPK	Class II	1997-08-26
K972231	Osom Mono Test 143	Wyntek Diagnostics, Inc.	KTN	Class II	1997-08-26
K972183	Depuy Ace A.i.m. Titanium Tibial Nail	Ace Medical	HSB	Class II	1997-08-26
K972135	Maersk Medical Pureline Comfort Subcutaneous Infusion Set	P/L Biomedical	FPA	Class II	1997-08-26
K972134	Bag Decanter	Remington Medical	LHI	Class II	1997-08-26
K972117	Msi Bottleflow, Transflow, Vialflow	Medical Specialty Innovations, Inc. (Msi)	LHI	Class II	1997-08-26
K972013	National Medical Healthcare Custom Ob/gyn Kits, Trays, or Packs	National Healthcare Mfg. Corp.	KNA	Class II	1997-08-26
K971986	Valley Forge Bipolar Loop	Valley Forge Scientific Corp.	HGI	Class II	1997-08-26
K971763	Blood Collection Tube Holder Vanishpoint Tube Holder/small Tube Adapter	Retractable Technologies, Inc.	FMI	Class II	1997-08-26
K971736	Sysmex Immature Reticulocyte Fraction (Irf) Parameter	Sysmex Corporation	GKZ	Class II	1997-08-26
K970927	Bruno Electra-Ride III Stairway Elevator System	Bruno Independent Living Aids, Inc.	ILK	Class II	1997-08-26
K970836	Trucount Absolute Count Tubes/counting Control Beads	Becton Dickinson Immunocytometry Systems	GKZ	Class II	1997-08-26
K970636	Totalcare., Modular Therapy System (Mts)	Hill-Rom Inc.	IOQ	Class II	1997-08-26
K970165	Evita 2 Dura	Drager, Inc.	CBK	Class II	1997-08-26
K972938	Aurecast 10	Aurex Precious Metal Industries (Pty)Ltd	EJT	Class II	1997-08-25
K972937	Aurecast 4	Aurex Precious Metal Industries (Pty)Ltd	EJT	Class II	1997-08-25
K972936	Aurecast 2	Aurex Precious Metal Industries (Pty)Ltd	EJT	Class II	1997-08-25
K972717	Ruff Work Eyegear	Ruff House, Inc.	HQY	Class I	1997-08-25
K972564	Tilt Master Cg System (Center of Gravity), Tilt-N-Space-Seat	Mechanical Application Designs, Inc.	ITI	Class II	1997-08-25
K972428	Extrawear, Gentlemen's Choice	Custom Services Intl., Inc.	HIS	Class II	1997-08-25
K972396	Vista Antigen Brucella Melitensis	Lee Laboratories, Inc.	GSO	Class II	1997-08-25
K972395	Vista Antigen Salmonella O Group D	Lee Laboratories, Inc.	GNC	Class II	1997-08-25
K972394	Vista Antigen Brucella Abortus	Lee Laboratories, Inc.	GSO	Class II	1997-08-25
K972392	Vista Antigen Salmonella H a	Lee Laboratories, Inc.	GNC	Class II	1997-08-25
K972391	Vista Antigen Salmonella H B	Lee Laboratories, Inc.	GNC	Class II	1997-08-25
K972390	Vista Antigen Salmonella H C	Lee Laboratories, Inc.	GNC	Class II	1997-08-25
K972389	Vista Antigen Salmonella H D	Lee Laboratories, Inc.	GNC	Class II	1997-08-25
K972388	Vista Antigen Salmonella O Group C	Lee Laboratories, Inc.	GNC	Class II	1997-08-25
K972387	Vista Antigen Salmonella O Group a	Lee Laboratories, Inc.	GNC	Class II	1997-08-25
K972386	Vista Antigen Salmonella O Group B	Lee Laboratories, Inc.	GNC	Class II	1997-08-25
K972196	Osteo Anatomical Bone Plates	Osteonics Corp.	HRS	Class II	1997-08-25
K972147	Peachtree Proportional Head Control Unit (Phc-2)	Dynamic Systems, Inc.	ITI	Class II	1997-08-25
K972142	Acs Hi-Torque All Star 0.014 Guide Wire with Microglide Coating	Boston Scientific Corporation	DQX	Class II	1997-08-25