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 1771 of 3531

510(k) clearances, page 1771 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K981997	Posi-Stop/posi-Trac System	The Dental Medical Device Co., LLC	DZE	Class II	1999-01-12
K981432	Goldman Manual Tonometer	Golden Vision, Inc.	HKY	Class II	1999-01-12
K984516	The Aptus (Automated) Application of the Mpo Elisa Test System. an Enzyme Linked Immunosorbent Assay (Elisa) for the Det	Zeus Scientific LLC	MOB	Class II	1999-01-11
K984456	Cobe Hvr 4000 Filtered Hardshell Venous Reservoir	LivaNova USA, Inc.	DTN	Class II	1999-01-11
K984444	Insight Gastrointestinal Motility System, Model S980000	Diversatek Healthcare Inc	FFX	Class II	1999-01-11
K984153	The Aptus (Automated) Application of the Mycoplasma Igm Elisa Test System.	Zeus Scientific LLC	LJZ	Class I	1999-01-11
K984139	The Aptus (Automated) Application of the Cmv Igg Elisa Test System. an Enzyme Linked Immunosorbent Assay (Elisa) for the	Zeus Scientific LLC	LFZ	Class II	1999-01-11
K984133	The Aptus (Automated) Application of the Ebna Igg Elisa Test System. an Enzyme Linked Immunosorbent Assay (Elisa) for Th	Zeus Scientific LLC	LLM	Class I	1999-01-11
K984126	The Aptus (Automated) Application of the Ebv-Vca Igg Elisa Test System. an Enzyme Linked Immunosorbent Assay (Elisa) for	Zeus Scientific LLC	MCD	Class I	1999-01-11
K984123	The Aptus (Automated) Application of the Legionella Igg/a/m (Elisa) Test System. an Enzyme Linked Immunosorbent Assay (E	Zeus Scientific LLC	LHL	Class II	1999-01-11
K983849	Dimension Automated High Density Lipoprotein Cholesterol (Adhl) Flex Reagent Cartridge	Siemens Healthcare Diagnostics Inc.	JHM	Class I	1999-01-11
K983635	Julian Anesthesia Workstation, Model # Julian	Draeger, Inc.	BSZ	Class II	1999-01-11
K983625	S555 Intraoral Dental Camera	Sopro	EIA	Class I	1999-01-11
K983597	Neuroline, Disposable Monopolar Needle Electrodes	Medicotest, Inc.	GXZ	Class II	1999-01-11
K983566	3-Chip Video Camera	Stryker Corp.	GCJ	Class II	1999-01-11
K983563	Imcor 4.00 & 5.00Mm Self-Tapping Locktite Implants, Imcor 4.00 & 5.00Mm Self-Tapping Ha Coasted Locktite Implants, and I	Imcor	DZE	Class II	1999-01-11
K983399	Giardia/cryptosporidium Combo Rapid Assay	Sekisui Diagnostics, LLC	MHI	Class II	1999-01-11
K981625	Sterrad 50 Sterilizer	Advanced Sterilization Products	MLR	Class II	1999-01-11
K984493	Maxxim; Maxxim Hd	Major Mobility Products, Inc.	IOR	Class I	1999-01-08
K984447	Model Action at II Manual Wheelchair	Invacare GmbH	IOR	Class I	1999-01-08
K984356	Nitrile Patient Examination Glove, Blue or Green Colored (Prepowdered Usp)	Perusahaan Getah Asas Sdn. Bhd.	LZA	Class I	1999-01-08
K984341	Sternvantage Varnish Lc, Model 221001	Sterngold/Implamed	EBI	Class II	1999-01-08
K984340	Sternomega Temporary Cement Automix Ne, Model 220282/220281	Sterngold/Implamed	EMA	Class II	1999-01-08
K984248	Procem	Espe Dental AG	EMA	Class II	1999-01-08
K984246	Prompt L-Pop	Espe Dental AG	KLE	Class II	1999-01-08
K984064	Omnigrip, Latex Surgical Glove, Powder Free	Omni Intl., Inc.	KGO	Class I	1999-01-08
K983994	Unifine	Owen Mumford USA, Inc.	FMF	Class II	1999-01-08
K983962	Ultrafree Textured Sterile Latex Powder-Free Surgical Gloves	Medtronic, Inc.	KGO	Class I	1999-01-08
K983707	Jms Dialyzer Priming Set	JMS Co., Ltd.	KOC	Class II	1999-01-08
K983620	Manan Spinal Needles	Argon Medical Devices, Inc	BSP	Class II	1999-01-08
K983607	Labtician Lid Load Gold Eyelid Weight Implants	Labtician Ophthalmics, Inc.	MML	Class II	1999-01-08
K983574	Stardental Titan 3 Lubefree Motor Attachments	Dentalez Group	EGS	Class I	1999-01-08
K983569	Ksea Monopolar Vaporization Electrodes	Karl Storz Endoscopy-America, Inc.	HIH	Class II	1999-01-08
K982754	Ec-1000-7 Digital Endoscopy Video Camera, Models Ec 1000-7P (Pal) & Ec 1000-7N (Ntsc)	A.Stein - Regulatory Affairs Consulting	FWF	Class I	1999-01-08
K982272	Galeo Hs 014 Model 117 130, Galeo S 014 Model 115 488, Galeao M 014 Model 114156, Galeo F 014 Model 115 487 Galeo HF 018	BIOTRONIK AG	DQX	Class II	1999-01-08
K982181	Trumist Breath Actuated Disposable Nebulizer	Trudell Medical	CAF	Class II	1999-01-08
K962918	Lidco System	Lidco, Ltd.	DXG	Class II	1999-01-08
K984438	Modified Auto Suturevcs* Anastomotic**clip Cartridge	United States Surgical, A Division of Tyco Healthc	FZP	Class II	1999-01-07
K984435	Medtronic Khonsari Annuloplasty Band, Model H609m	Medtronic, Inc.	KRH	Class II	1999-01-07
K984197	Fluorotex Surgical Mesh	Bridger Biomed, Inc.	FTL	Class II	1999-01-07
K984068	Flamingo Wallstent Esophageal Endoprosthesis	Schneider (Europe) GmbH	ESW	Class II	1999-01-07
K983977	Light Age Epicare Alexandrite Laser	Light Age, Inc.	GEX	Class II	1999-01-07
K983902	Field Effects MRI System	Intermagnetics General Corp.	LNH	Class II	1999-01-07
K983735	Pall Dental Filtration System with Air Water Syringe Housing and Filter Membrane	Pall Medical	EIA	Class I	1999-01-07
K983567	Image Technologies Stericam, Coupler-Drape and Troview Imaging System	Med Images, Inc.	GCJ	Class II	1999-01-07
K983558	Acetal Dental/preformed Clasp	Dentamax, Inc.	EHP	Class I	1999-01-07
K983552	Basic, Median, Dominant, and Vario	Medela AG	BTA	Class II	1999-01-07
K983550	Xyz System	Bio-Monitoring International Corp.	HCC	Class II	1999-01-07
K983547	Protech Plus	Protech, Inc.	EBI	Class II	1999-01-07
K972335	Cleancut	Medquest Products, Inc.	GEI	Class II	1999-01-07