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 2026-11-02, 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 953 of 3531

510(k) clearances, page 953 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K110922	Patient Monitor	Edan Instruments, Inc.	MHX	Class II	2011-07-20
K110867	Steri-Dent, Steri-Sure	Cpac, Inc.	FRG	Class II	2011-07-20
K110797	Communify Pacs Viewer	Flying Squirrel Storage, LLC	LLZ	Class II	2011-07-20
K110608	Sevoflurane Vaporizer Adaptor	Piramal Critcal Care, Inc (Formerly Minrad, Inc)	CAD	Class II	2011-07-20
K110227	Optima Ct660	GE Healthcare	JAK	Class II	2011-07-20
K110213	Ge Datex-Ohmeda Aisys	GE Healthcare	BSZ	Class II	2011-07-20
K103745	Biotene Moisturizing Mouth Spray for Dry Mouth Symptom Relief	Glaxosmithkline Consumer Healthcare (Gskch)	LFD	Unclassified	2011-07-20
K102401	Hemi Implant; Mini Hemi Implant	Vilex LLC	KWD	Class II	2011-07-20
K102286	Crag Lateral Flow Assay (Crag Lfa)	IMMY, Inc.	GMD	Class II	2011-07-20
K093548	Avie A1c Test System	Mec Dynamics Corp	LCP	Class II	2011-07-20
K111897	Abl90	Radiometer Medical ApS	CHL	Class II	2011-07-19
K111835	Plateau Spacer System	Life Spine	ODP	Class II	2011-07-19
K111725	Mobilediagnost Wdr	Sedecal S.A.	IZL	Class II	2011-07-19
K111495	Cook Gi Endoscopic Injection Gel Kit, Gel-S, Gel-N, Gel-H, Gel-K	Wilson-Cook Medical Inc.	FBK	Class II	2011-07-19
K111469	Staxxsd System	Spine Wave Inc	MQP	Class II	2011-07-19
K111380	Neuron Max System	Penumbra Inc.	DQY	Class II	2011-07-19
K111304	Optima Xr120	GE Healthcare	IXL	Class II	2011-07-19
K111147	Medline Vessel Cannula	MEDLINE INDUSTRIES, LP - Northfield	DWF	Class II	2011-07-19
K110852	Dolphin 3 Fluid Management System	Gyrus ACMI, Inc.	HIG	Class II	2011-07-19
K110556	Mini Telemetry System	Wipro GE Healthcare Private Ltd.	HGM	Class II	2011-07-19
K110443	Bd Insyte Autoguard Bc	Becton Dickinson & Co	FOZ	Class II	2011-07-19
K103676	Fujirebio Diagnostics Tumor Marker Control	Fujirebio Diagnostics, Inc.	OIU	Class II	2011-07-19
K103129	Entropy Easyfit Sensor	GE Healthcare	GWQ	Class II	2011-07-19
K101407	Alpha Histoplasma Antigen Eia Model Hag102	IMMY, Inc.	MIZ	Class II	2011-07-19
K101181	Bel-Cat	Takara Belmont Corporation	OAS	Class II	2011-07-19
K111144	Candela Gentlelase Family of Lasers	Candela Corporation	GEX	Class II	2011-07-18
K111002	Reprocessed Endoscopic Trocars	Sterilmed Inc	NLM	Class II	2011-07-18
K110956	Medivance Nasogastric Tube Temperature Sensor	Medivance Inc.	FLL	Class II	2011-07-18
K110439	Domain Surgical System	Omni-Guide Holdings, Inc.	GEI	Class II	2011-07-18
K110189	Reprocessed Electrosurgical Instrument	Stryker Sustainability Solutions	NUJ	Class II	2011-07-18
K103731	Capstone R Spinal System	Medtronic Sofamor Danek	MAX	Class II	2011-07-18
K111864	E-Cube 9	ALPINION MEDICAL SYSTEMS Co., Ltd.	IYN	Class II	2011-07-15
K111803	G-Scan	Esaote S.p.A.	LNH	Class II	2011-07-15
K111706	Volcano S5iintravascular Imaging and Pressure System	Volcano Corporation	IYO	Class II	2011-07-15
K111560	Wondfo Amphetamine Urine Test, Wondfo Barbiturates Urine Test, Wondfo Benzodiazepines Urine Test	Guangzhou Wondfo Biotech Co., Ltd.	DKZ	Class II	2011-07-15
K111417	The Powerwand (R) Safety Introducer with an Extended Dwell Catheter	Access Scientific, Inc.	DYB	Class II	2011-07-15
K111416	Falcon	Viasonix Ltd.	JOP	Class II	2011-07-15
K111328	Powder Free Nitrile Examination Gloves	Gx Corporation Sdn Bhd	LZA	Class I	2011-07-15
K111045	Centro Family of Manual Wheelchairs	Otto Bock Healthcare LP	IOR	Class I	2011-07-15
K110928	Body Analysis Scale, Model Bg 17	Shenzhen Healthcare Electronic Technology Co., Ltd.	MNW	Class II	2011-07-15
K110857	Powder-Free Vinyl Patient Examination Gloves, Yellow Color	Shandong Zhanpeng Medical Products Company Limited	LYZ	Class I	2011-07-15
K110847	Smr Shoulder System - Cta Humeral Heads	Lima Corporate S.p.A.	KWS	Class II	2011-07-15
K110328	Acg-8511 Portable ECG Monitor	Andon Health Co., Ltd	DPS	Class II	2011-07-15
K110298	Opiate Enzyme Immunoassay	Lin-Zhi International Inc	DJG	Class II	2011-07-15
K110197	Exactech Gibralt Spinal System	Exactech, Inc.	MNI	Class II	2011-07-15
K103685	Pulse Oximeter Sensor (Disposable and Reusable) Model Rsa002dn, Rsj002da, Rsj091di, Rst063ca	Beijing Rongrui-Century Scie. & Tech. Co., Ltd.	DQA	Class II	2011-07-15
K102643	Spotcheck Neonatal Galt Microplate Reagent Kit	Astoria-Pacific, Inc.	KQP	Class II	2011-07-15
K093755	Ag-695 Single and Multi Blood Glucose Monitoring System/ag-696 Single and Multi Blood Glucose Monitoring System	Andon Medical co., Ltd	NBW	Class II	2011-07-15
K111856	Soft Grip Contact Lens Case, Deluxe Contact Lens Case, Econo-Mate Contact Lens Case	Apothecary Products, LLC	LRX	Class II	2011-07-14
K111240	Disposable Powder Free Vinyl Synthetic Examination Glove, Blue Color	Xuzhou Full Sun Medical Products Ltd.	LYZ	Class I	2011-07-14