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 1932 of 3531

510(k) clearances, page 1932 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K961883	Versa-Cath Arterial Catheter	Ideas for Medicine, Inc.	DXE	Class II	1997-01-13
K960511	Gibeck Warmbag Reusable Convective Warming Blanket	Gibeck, Inc.	DWJ	Class II	1997-01-13
K965080	Anspach Micromax System	The Anspach Effort, Inc.	ERL	Class II	1997-01-10
K964916	Gamma-Glutamyl Transpeptidase	Derma Media Lab., Inc.	JQB	Class I	1997-01-10
K964580	Cap-Aid (Improved)	Nebel, Inc.	FHA	Class I	1997-01-10
K964576	Profile Mammography System (M-Pro)	Bennett X-Ray Corp.	IZH	Class II	1997-01-10
K964505	Gianni Versace Sunglasses, Versus Sunglasses, Diablo Sunglasses	I C Optics, Ltd.	HQY	Class I	1997-01-10
K964450	Secondary Trocar and Sleeve with Insufflation Port	Pilling Weck Group	HET	Class II	1997-01-10
K964370	Magnetic Resonance Diagnostic System	GE Healthcare	LNH	Class II	1997-01-10
K964340	Portarem-3000, Pfs-6000	Starkey Laboratories, Inc.	EWO	Class II	1997-01-10
K964324	Multitak Ss Suture System	Bonutti Research, Inc.	MBI	Class II	1997-01-10
K964318	Philips Tomoscan Av Expander Upgrade	Philips North America LLC	JAK	Class II	1997-01-10
K964274	Writestar, and Viewstar	Comview Corp.	LMB	Class I	1997-01-10
K964138	Varian Ximatron C-Series Radiation Therapy Simulator with Version 4.2 Software	Varian Medical Systems, Inc.	KPQ	Class II	1997-01-10
K964136	Hystero CO2-Pneu 2221	Richard Wolf Medical Instruments Corp.	HIG	Class II	1997-01-10
K964130	Aerogear Asthma Action Kit	Monaghan Medical Corp.	BZH	Class II	1997-01-10
K964078	3050 Sport-Neb	Medical Industries America, Inc.	CAF	Class II	1997-01-10
K963950	Bioderm Eid Male External Incontinence Device	Bioderm, Inc.	EXI	Class I	1997-01-10
K963674	Lumex Air	Lumex, Inc.	FNM	Class II	1997-01-10
K963221	Optical Digitizer Option for View Point	Philips North America LLC	HAW	Class II	1997-01-10
K962995	Ilo88. Otodynamic Analyser, Kit System for Pc	Otodynamics, Ltd.	EWO	Class II	1997-01-10
K962983	Sterile Soft-Temp	Adroit Medical Systems, Inc.	ILO	Class II	1997-01-10
K962902	Fotona Skinlight Laser System	Medical Laser Solutions	GEX	Class II	1997-01-10
K962683	Snowden-Pencer Computerized High Flow Insufflator	Deknatel, Inc.	HIF	Class II	1997-01-10
K962320	S3 Cardioplegia Control	Stoeckert Instrumente	DTR	Class II	1997-01-10
K962249	Pixell MRI System	General Medical Equipment Corp.	LNH	Class II	1997-01-10
K962239	Smart Adjuster (Sa201)	Sigma	LXM	Unclassified	1997-01-10
K962100	Volmetric Coincidence Detection System	Elscint, Inc.	KPS	Class II	1997-01-10
K962001	Manan Pediatric Bone Marrow Access Needle	Argon Medical Devices, Inc	FMI	Class II	1997-01-10
K960966	Hepa-Type Air Cleaner Model 2586 and True Hepa Air Cleaner Models 2587 and 2588	Sunbeam-Oster Household Products	FRF	Class II	1997-01-10
K955384	Drake Willock System 1000 Dialysate Delivery System W/single Needle Single Lumen Option	Althin Medical AB an Affiliate of Baxter Intl	KDI	Class II	1997-01-10
K965084	Vidas Proesterone (Prg) (30 409)	bioMerieux, Inc.	JLS	Class I	1997-01-09
K964912	Lactate Dehydrogenase	Derma Media Lab., Inc.	CFJ	Class II	1997-01-09
K964643	Suretemp	Diatek Instruments, Inc.	FLL	Class II	1997-01-09
K964620	Panogauze Non-Woven Hydrogel Dressing	Sage Pharmaceuticals, Inc.	MGQ	Unclassified	1997-01-09
K964602	Davis Bayonet Electrodes	Medtronic, Inc.	GEI	Class II	1997-01-09
K964338	Ri-Tiniscope-Slit/ri-Tiniscope Spot/ri-Vision-Slit/ri-Vision-Spot	Rudolf Riester GmbH & Co. KG	HKM	Class I	1997-01-09
K964321	Glove, Patient Examination, Vinyl (Powdered)	Shijiazhuang Hongray Plastic Products Co., Ltd.	LYZ	Class I	1997-01-09
K964290	Eyechek	Reichert Ophthalmic Instruments, Div. Leica, Inc.	HLQ	Class I	1997-01-09
K964259	Synthes (USA) Ddhs/dcs System Modification	Synthes (USA) Products LLC	JDO	Class II	1997-01-09
K964179	Super-Dent Etching Gel, Super-Dent Micro-Etch Gel and Super-Dent Etching Gel Syringe Tips	S.S. White Mfg., Ltd.	EBF	Class II	1997-01-09
K964143	Mini-Symm Bipolar Coagulator	Valley Forge Scientific Corp.	GEI	Class II	1997-01-09
K964133	American Dental Products Hg 35 Desensitizer with Fluoride	American Dental Products, Inc.	KLE	Class II	1997-01-09
K963506	Tenet Radiolucent Hand Table	Tenet Medical Engineering	FQO	Class I	1997-01-09
K963357	Modification to the Synthes (USA) Universal Spinal Hook, Rod, and and Sacral Screw Fixation System in 316L Stainless Ste	Synthes (USA) Products LLC	MNH	Class II	1997-01-09
K963109	Heritage Hip System	Zimmer GmbH	JDI	Class II	1997-01-09
K963091	Vollman Prone Positioner	Hill-Rom Inc.	IPT	Class I	1997-01-09
K962989	Amoils Epithelial Scrubber	S. Percy Amoils	HOG	Class I	1997-01-09
K962965	Lightstic Model 360	Rare Earth Medical, Inc.	GEX	Class II	1997-01-09
K960121	Autolink Body Plethysmograph	P.K. Morgan, Ltd.	BZC	Class II	1997-01-09