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 2026-11-09, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,227 of the 176,624 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	2,827

176,624 records, page 1732 of 3533

510(k) clearances, page 1732 of 3533
K number	Device	Applicant	Product code	Class	Decision date
K992346	Kinematic II Rotating Hinge Knee	Howmedica Osteonics Corp	LGE	Class II	1999-08-12
K992109	Encore Fully Coated Hip	Encore Orthopedics, Inc.	LPH	Class II	1999-08-12
K992052	Models Lynx and Panther Motorized Scooters	Invacare GmbH	INI	Class II	1999-08-12
K992035	Manual Wheelchair	Major Mobility Products, Inc.	IOR	Class I	1999-08-12
K992029	Atac Direct Hdl Cholesterol Reagent and Atac Hdl-C Calibrator Kits	Elan Diagnostics	LBR	Class I	1999-08-12
K991950	Laglove Brand Nitrile Surgical Glove-Sterile (Powder-Free)	La Glove (M) Sdn. Bhd.	KGO	Class I	1999-08-12
K991949	Laglove Brand Nitrile Surgical Glove-Sterile (Powdered)	La Glove (M) Sdn. Bhd.	KGO	Class I	1999-08-12
K991931	Ctd Mark I Traction Device	Therasys, Inc.	ITH	Class II	1999-08-12
K991920	Dermaphylyx Hydrophilic Foam Wound Dressing	Dermaphylyx, Inc.	KMF	Class I	1999-08-12
K991895	Rampipella, Singe Port (720196) & Wedge-Shaped Port (720217)	Ri Mos. S.r.l.	HHK	Class II	1999-08-12
K991889	Ultimax Haig II Nail System	Encore Orthopedics, Inc.	LXT	Class II	1999-08-12
K991820	Helicobacter Pylori Igg Elisa Test System. an Enzyme Linked Immunosorbent Assay (Elisa)for the Detection of Igg Antibodi	Zeus Scientific LLC	LYR	Class I	1999-08-12
K991792	Cryo-Mono Cryogenic System, Model Cryo-Mono with Tuf Probe	Influence, Inc.	GEH	Class II	1999-08-12
K991791	Sound Vaser System	Solta Medical, Inc.	LFL	Unclassified	1999-08-12
K991757	Non-Absorbable Gauze for External Use, Sterile and Non Sterile	Furlong Industries	EFQ	Unclassified	1999-08-12
K991718	Operating Laparoscope, 10-5 Mm, Angeled, Operating Laparoscope 12-7Mm, Angled, Operating Laparoscope, 10-5,,. Oblique, D	Richard Wolf Medical Instruments Corp.	GCJ	Class II	1999-08-12
K991678	Whiteside Biomechanics Spinal System	Whiteside Biomechanics, Inc.	KWQ	Class II	1999-08-12
K991674	Cordis Palmaz Corinthian Transhepatic Biliary Stent and Delivery System, Models Pc155bjs, Pci156bjs, Pc185bjs, Pc186bjs	Cordis US Corp.	FGE	Class II	1999-08-12
K991669	Pms 750 Fingerswitch	CooperSurgical, Inc.	GEI	Class II	1999-08-12
K990907	Remote Introducer, Model Pi-1000	Image-Guided Neurologics, Inc.	HAW	Class II	1999-08-12
K990440	Gentell Hydrogel Spray Gel, Appligard Squeeze	Gentell	MGQ	Unclassified	1999-08-12
K990428	Drainage Bag	Remington Medical	EXF	Class II	1999-08-12
K984569	Ab2 Med-Flo Solution Set	Ab2 Medical Products, LLP	FPA	Class II	1999-08-12
K984567	Ventana Er Primary Antibody (Clone 6F11)	Ventana, Inc.	MYA	Class II	1999-08-12
K984304	Riwo Drive Generator	Richard Wolf Medical Instruments Corp.	HRX	Class II	1999-08-12
K983395	Fetalgard 3000 Fetal Monitor	Analogic Corp.	HGM	Class II	1999-08-12
K982969	Nonin Pulse Oximeter and Carbon Dioxide Detector, Models 9843, 9845 and 9847	Nonin Medical, Inc	CCK	Class II	1999-08-12
K982724	Theradyne Rover Powered Wheelchair	Kurt Mfg. Co.	ITI	Class II	1999-08-12
K992550	Liquichek Immunology Control Level 1, 2, 3	Bio-Rad	JJY	Class I	1999-08-11
K991839	Abx Pentra 120 Retic Automated Hematology Analyzer	Horiba Instruments Incorporated	GKZ	Class II	1999-08-11
K991779	Nitrile Examination Gloves Powder Free (Blue)	Seltom Pacific Sdn. Bhd.	LZA	Class I	1999-08-11
K991776	Nitrile Examination Gloves Powder Free (White)	Seltom Pacific Sdn. Bhd.	LZA	Class I	1999-08-11
K991481	Paragon	Lancer Orthodontics, Inc.	EJJ	Class II	1999-08-11
K991268	Gonostat Gonococcal Detection Kit	Sierra Diagnostics	LSL	Class II	1999-08-11
K990545	Jetsonic 2000	Sds Dental, Inc.	KOJ	Class II	1999-08-11
K983364	Buffalo Filter Virosafe 18 Filter-Catalog #Vso1801	Buffalo Filter Co., Inc.	FYD	Class II	1999-08-11
K983333	Buffalo Filter Virosafe Hrf- #Vshrfo1	Buffalo Filter Co., Inc.	FYD	Class II	1999-08-11
K992503	Sechrist Air-Oxygen Mixer, 3500/3500Hl Series	Sechrist Industries Inc	BZR	Class II	1999-08-10
K992422	Accusign Doa3,doa, Coc/thc/opi2000 Doa3; Biosign Doa3, Coc/thc/opi2000; Status Ds Coc/thc/opi2000	Princeton BioMeditech Corp.	DJG	Class II	1999-08-10
K992365	Aia-Pack Folate Assay	Tosoh Medics, Inc.	CGN	Class II	1999-08-10
K992252	Light Diagnostics Pneumocystis Carinii Dfa, Model 31965	Chemicon Intl., Inc.	LYF	Class II	1999-08-10
K992051	Radifocus Optitorque	Terumo Medical Corp.	DQO	Class II	1999-08-10
K991938	Caphosol Artificial Saliva	Inpharma A.S.	LFD	Unclassified	1999-08-10
K991826	Planmed Sophie and Sophie Classic	Planmed Oy	IZH	Class II	1999-08-10
K991766	ECG-Gating System for Aquilion CT Scanner, Tsx-101A	Toshiba America Medical Systems, In.C	JAK	Class II	1999-08-10
K991717	Careside Mg	Careside, Inc.	JGJ	Class I	1999-08-10
K991701	Mach-Sigma Handpiece, Ultrapush, Models Mach-Sigma Mu (Mini Head), Mach-Sigma Su (Std. Head), Mach-Sigma Tu (Torque Hd)	Nsk Nakanishi, Inc.	EFB	Class I	1999-08-10
K991665	Hdl Cholesterol, Product No's 124-01, Ch102-01	A.P. Total Care, Inc.	LBS	Class I	1999-08-10
K991634	Fotona Novalis R Ruby Laser System	Fotona D.D.	GEX	Class II	1999-08-10
K991632	Fotona Novalis Er: Yag Laser System	Fotona D.D.	GEX	Class II	1999-08-10