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 1863 of 3531

510(k) clearances, page 1863 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K971013	Chase Temperature Probe	Chase Medical, Inc.	DTN	Class II	1997-10-28
K970264	Cordis Webster Braided Guiding Sheath Exchange System	Cordis Webster, Inc.	DYB	Class II	1997-10-28
K963502	Csco Forehead Fixation System	Howmedica Corp.	MBI	Class II	1997-10-28
K973832	Opus Hlh Controls	Behring Diagnostics, Inc.	JJX	Class I	1997-10-27
K973352	Brand Name *1-Step Pregnancy	Armkel, LLC	LCX	Class II	1997-10-27
K973310	Tbd* One-Step Ovulation Predictor Test	Armkel, LLC	CEP	Class I	1997-10-27
K973234	Midas Touch Electrosurgical Electrode	Iti Medical Technologies, Inc.	GEI	Class II	1997-10-27
K973098	Compression Cerclage Gundolf Ccg-Gf	Plus Orthopedics	JDQ	Class II	1997-10-27
K973043	Model C-1 Hearing Aid	Better Hearing, Inc.	ESD	Class I	1997-10-27
K972933	Vox/base for Windows	J-Mac System, Inc.	LLZ	Class II	1997-10-27
K972923	Super Siliplugs Ear Plugs	Interview Medical Technology Corp.	EWD	Unclassified	1997-10-27
K972918	Rapid Fire Hair Implanter Carousel	Apex Medical Products, LLC	GAH	Class I	1997-10-27
K972274	Spife	Helena Laboratories, Corp.	CEF	Class I	1997-10-27
K972015	Hydragel 7,15,30, Chol-Hdl Kit	Morax	LBT	Class I	1997-10-27
K971367	Brainscan Conformal Rt Module	Brainlab, Inc.	IYE	Class II	1997-10-27
K971313	Nmc Hemodialysis Arterial Blood Tubing Set	National Medical Care, Inc.	FJK	Class II	1997-10-27
K971259	Combiport Fluid Lavage Device	B.Braun Medical, Inc.	KDH	Class II	1997-10-27
K970971	Uro Med Nerve Stimulator	Uromed Corp.	ETN	Class II	1997-10-27
K973654	Vial-Mate Reconstitution Device (2B8071)	Baxter Healthcare Corporation	LHI	Class II	1997-10-24
K973574	Duralastic Anatomical Malar Implant	Hanson Medical, Inc.	LZK	Class II	1997-10-24
K973466	Hanaulux Blue 75 and Hanaulux Blue 120	Heraeus Med GmbH	FSY	Class II	1997-10-24
K973195	Total Performance System Shaver	Stryker Corp.	HRX	Class II	1997-10-24
K973071	Tri Talon Retrieval Forceps	Medical Engineering Laboratory, Inc.	OCZ	Class II	1997-10-24
K972867	Craft Duo-Vac Suction Unit, Craft Suction Unit	Rocket Medical	ICX	Class I	1997-10-24
K972808	Hansatome Microkeratome	Chiron Vision Corp.	HNO	Class I	1997-10-24
K972621	Profeel Powder Free Surgical Gloves (Protein Content Labeling)	Wembley Rubber Products (M) Sdn Bhd	KGO	Class I	1997-10-24
K972471	Digital 3-Chip Color Video Camera, Illuminators, Video Components and Accessories	Smith & Nephew, Inc.	GCJ	Class II	1997-10-24
K972028	Dermascan Surgical Laser Scanner	Esc Medical Systems, Ltd.	GEX	Class II	1997-10-24
K971680	Auto Suture Bone Wax	United States Surgical, A Division of Tyco Healthc	MTJ	Unclassified	1997-10-24
K971588	Evi Sutured-Clip Applier	Elective Vascular Intervention Inc. (Evi)	FZP	Class II	1997-10-24
K971018	Smc Acetabular Component	Whiteside Biomechanics, Inc.	LPH	Class II	1997-10-24
K970595	Circon Endotek Om-4 H2o Cystometry Pump	Circon Video	FEN	Class II	1997-10-24
K964398	Spyroflex Pigmented Wound Dressing/spyroflex Wound Dressing Tinted	Polymedica Industries, Inc.	MGP	Unclassified	1997-10-24
K972804	Bang Polymer Gel Dosimeter, Bang 533	Mgs Research, Inc.	IYE	Class II	1997-10-23
K971980	Mcd-Ac	Philips North America LLC	KPS	Class II	1997-10-23
K971265	Viking Diagnostic Electrode Catheter	C.R. Bard Inc	DRF	Class II	1997-10-23
K962783	Edema System	Bioanalogics, Inc.	DSB	Class II	1997-10-23
K955243	Bariair	KCI USA, Inc.	FNM	Class II	1997-10-23
K973588	Liquid Alkaline Phoshatase Reagent Set	Horiba Instruments Incorporated	CJE	Class II	1997-10-22
K973464	Quantex RF Plus (Latex, Buffer, Standard, Control)	Instrumentation Laboratory Co.	DHR	Class II	1997-10-22
K973331	Vitros Immunodiagnostic Products Ferritin Reagent Pack (Gem.1340), Ferritin Calibrators (Gem.c340)	Ortho-Clinical Diagnostics, Inc.	DBF	Class II	1997-10-22
K973312	Transparent Film Dressing, Intelligent Film Dressing	Innovative Technologies, Ltd.	MGP	Unclassified	1997-10-22
K972880	Mdp2000 Medical Data Processor	Vidco, Inc.	MSX	Class II	1997-10-22
K972836	Royale Brand Latex Condoms-Spermicidal Lubricant - Colored or Assorted Colors	G. Premjee (USA), Inc.	LTZ	Class II	1997-10-22
K972760	Link, Acetabular Revision Mesh Cup	Link America, Inc.	JDJ	Class II	1997-10-22
K972695	Finally Free	Mehl/Group Marketing	KCX	Class I	1997-10-22
K971989	Toxoplasma Igm Assay for the Bayer Immuno1 System (in Vitro Diagnostic System)	Bayer Corp.	LGD	Class II	1997-10-22
K971683	Wireless Lan (Local Area Network) - Wireless Ethernet	Marquette Electronics, Inc.	MSX	Class II	1997-10-22
K971420	Microendoscope(8755.401,411,461,451)/external Sheath(8755.221,222)/veress Cannula(8755.211,212)	Richard Wolf Medical Instruments Corp.	HIH	Class II	1997-10-22
K971015	Ahcs Hemoperfusion System	American Health Care Systems, Inc.	FLD	Class II	1997-10-22