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 2026-10-21, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,018 of the 176,415 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	2,618

176,415 records, page 543 of 3529

510(k) clearances, page 543 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K172439	Siberian Fit	Vydence	GEX	Class II	2018-02-14
DEN170045	Banyan BTI	Banyan Biomarkers, Inc.	QAT	Class II	2018-02-14
K180288	QuickVue Influenza A+B	Ortho-Clinical Diagnostics, Inc.	PSZ	Class II	2018-02-13
K173592	MAGNETOM Aera, MAGNETOM Skyra/Skyrafit, MAGNETOM Prisma/Prismafit, MAGNETOM Avantofit	Siemens Medical Solutions USA, Inc.	LNH	Class II	2018-02-13
K173535	Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TAS Hyperlordotic Interbody Fusion Device and Endoskeleton® TCS Interbody Fusion Device	Titan Spine, LLC	ODP	Class II	2018-02-13
K173315	SupaChair Powered Wheelchair	Eurogreen International, Inc.	ITI	Class II	2018-02-13
K173313	SupaChair Powered Wheelchair: COMBI 18, COMBI 18SP, COMBI 20, COMBI 20SP	Eurogreen International, Inc.	ITI	Class II	2018-02-13
K173195	DRI Hydrocodone Assay	Microgenics Corporation	DJG	Class II	2018-02-13
K172870	Infra-red ear thermometer model: ET-100A, ET-100B, ET-100D, ET-100E, ET-100G, ET-100I, ET-100J	Hangzhou Hua'an Medical & Health Instruments Co.	FLL	Class II	2018-02-13
K172839	Endosolv	Septodont	KIF	Class II	2018-02-13
K172624	Voyant 5mm Fusion Device	Applied Medical Resources Corp	GEI	Class II	2018-02-13
K172058	Ct6485, Ct12885	Analogic Corp.	JAK	Class II	2018-02-13
K171825	Disposable Endoscopic Surgical Instrument, Reusable Endoscopic Surgical Instrument	Hunan Handlike Minimally Invasive Surgery Co., Ltd.	GEI	Class II	2018-02-13
DEN170073	ContaCT	Viz.Al, Inc.	QAS	Class II	2018-02-13
K180118	Arthrex NanoSuture Anchor	Arthrex GmbH	MBI	Class II	2018-02-12
K173710	MotoBAND CP Implant System	Crossroads Extremity Systems LLC	HWC	Class II	2018-02-12
K173670	CELERITY 20 Steam Incubator	STERIS Corporation	FRC	Class II	2018-02-12
K173634	CELERITY 20 Steam Biological Indicator	STERIS Corporation	FRC	Class II	2018-02-12
K173579	Thorecon™ Fixation System	A & E Medical Corporation	JDQ	Class II	2018-02-12
K173561	Vinyl Patient Examination Glove (Yellow)	Yurun Glove Co., Ltd.	LYZ	Class I	2018-02-12
K173527	Digitex Delivery Device	MEDLINE INDUSTRIES, LP - Northfield	PWI	Class II	2018-02-12
K172941	CASCADIA Interbody System	K2M, Inc	OVD	Class II	2018-02-12
K172883	Home Use Hair Removal Device/T1, T2, T3	Shenzhen Mareal Tech Co., Ltd	OHT	Class II	2018-02-12
K172775	MiniLap System with MiniGrip Handle, MiniLap System with ThumbGrip Handle	Teleflexmedical, Inc.	OCW	Class II	2018-02-12
K171933	ASAHI PTCA Guide Wires, ASAHI Corsair Microcatheter, ASAHI Corsair Pro Microcatheter	Asahi Intecc Co., Ltd.	DQX	Class II	2018-02-12
K171495	Zyston Strut Open Titanium Spacer System	Highridge Medical, LLC	MAX	Class II	2018-02-12
K170793	SuRgical Planner (SRP)	Surgical Theater Inc	LLZ	Class II	2018-02-12
K180082	geko T-2 and geko Plus R-2	Firstkind Ltd	IPF	Class II	2018-02-11
K170131	TAV Medical Dental Implants System	TAV Medical	DZE	Class II	2018-02-10
K180107	Blue Sky Bio Aligner	Blue Sky Bio, LLC	NXC	Class II	2018-02-09
K173894	Jade PTA Balloon Dilatation Catheter	Orbusneich Medical Trading, Inc.	LIT	Class II	2018-02-09
K173823	Amrad Medical AAU Digital Radiography System; Amrad Medical AAU Plus Digital Radiography System; Amrad Medical DFMT Digital Radiography System; Amrad Medical FMT Digital Radiography System	Summit Industries, LLC	KPR	Class II	2018-02-09
K173791	Leksell GammaPlan	Elekta Instrument AB	IWB	Class II	2018-02-09
K173523	BD Phoenix Automated Microbiology System - GN Meropenem-vaborbactam (0.125/8-32/8 ug/mL)	Becton Dickinson & Co	LON	Class II	2018-02-09
K173501	Meridian Vaginal Positioning System (VPS)	MEDLINE INDUSTRIES, LP - Northfield	PWK	Class II	2018-02-09
K173435	3M Attest Rapid Readout Biological Indicator	3M Company	FRC	Class II	2018-02-09
K173400	ORISE Tissue Retractor System	Boston Scientific Corporation	FED	Class II	2018-02-09
K173272	Ergonomic Handle	Symmetry Surgical GmbH	GCJ	Class II	2018-02-09
K173163	ChlorCid, ChlorCid V, ChlorCid Surf	Ultradent Products Inc.	KJJ	Unclassified	2018-02-09
K172755	PRO-LITE Sterilization Trays	STERIS Corporation	KCT	Class II	2018-02-09
K172754	V-PRO maX 2 Low Temperature Sterilization System	STERIS Corporation	MLR	Class II	2018-02-09
K172753	VERIFY VH2O2 Indicator Tape	STERIS Corporation	JOJ	Class II	2018-02-09
K172752	CELERITY 20 HP Biological Indicator	STERIS Corporation	FRC	Class II	2018-02-09
K172751	iVitri Straw	Reprobitech Corp.	MQK	Class II	2018-02-09
K172749	Vis-U-All Low Temperature Sterilization Pouch/Tubing	STERIS Corporation	FRG	Class II	2018-02-09
K172748	VERIFY V24 Self-Contained Biological Indicator, VERIFY V24 Biological Indicator Challenge Pack	Steris Corporations	FRC	Class II	2018-02-09
K172746	VERIFY® HPU Chemical Indicator and VERIFY® Vaporized VH2O2 Process Indicator Adhesive Label	STERIS Corporation	JOJ	Class II	2018-02-09
K172504	Tosama Biobased Applicator Tube Menstrual Tampon	TOSAMA d.o.o.	HEB	Class II	2018-02-09
K172422	Kohli Urinary Drainage Catheter	Nellie Medical, LLC	EZL	Class II	2018-02-09
K172284	NAPA LP-15 Airway Pressure Monitor	DRW Medical	CAP	Class II	2018-02-09