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 1383 of 3531

510(k) clearances, page 1383 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K041293	Biopore Balloon Dilation Catheter	Bipore, Inc.	LIT	Class II	2004-07-09
K040999	Tampax Tampons (Junior, Regular, Super and Super Plus Absorbencies)	Procter & Gamble Co.	HEB	Class II	2004-07-09
K040281	Lps Metaphyseal Sleeve (Limb Preservation System)	Depuy Orthopaedics Inc.	JWH	Class II	2004-07-09
K040266	Core Needle Biopsy	Remington Medical	KNW	Class II	2004-07-09
K041688	Ge Voluson 730 Pro/expert Untrasound Bt04	General Electric Co.	IYN	Class II	2004-07-08
K041622	Modification to Fabius Gs Anesthesia System; Fabius Tiro Anesthesia System	Draeger, Inc.	BSZ	Class II	2004-07-08
K041414	Crono and Crono, Model 30	Cane S.r.l.	FRN	Class II	2004-07-08
K041350	Synthes (USA) Chronos	Synthes (USA) Products LLC	GXP	Class II	2004-07-08
K041029	Kinetdx	Siemens Medi Cal Solutions, Inc.	LLZ	Class II	2004-07-08
K040970	Leonardo	Siemens Medical Solutions USA, Inc.	LLZ	Class II	2004-07-08
K040961	Injector Needle/snare	United States Endoscopy Group, Inc.	FDI	Class II	2004-07-08
K040841	Powder Free Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs)	MEDLINE INDUSTRIES, LP - Northfield	LZA	Class I	2004-07-08
K040439	Mdi Trigger Guard	North American Technical Services (Nats) Corp.	CAF	Class II	2004-07-08
K031701	Osteomed Temporary Condylar Attachment System	Osteomed	NEI	Class II	2004-07-08
K031454	Acumen Surgical Navigation System	Zimmer GmbH	HAW	Class II	2004-07-08
K041608	C-Vue 55 Toric (Methafilcon a) Multifocal Contact Lens	Unilens Corp., USA	LPL	Class II	2004-07-07
K041606	Extractor Rx Retrieval Balloon	Boston Scientific Corporation	FGE	Class II	2004-07-07
K041584	Kyphx Hv-R Bone Cement, Model C01a	Medtronic, Inc.	NDN	Class II	2004-07-07
K041582	Modification to Tripter X-1 Compact Duet	Direx Systems Corp.	LNS	Class II	2004-07-07
K041551	Modification to: Hydrocoil Embolic System (Hes)	Terumo Cardiovascular Systems Corporation	HCG	Class II	2004-07-07
K041243	Dover Red Rubber Robinson Catheter	Tyco Healthcare	KOD	Class II	2004-07-07
K041140	Acell Ubm Surgical Mesh Ml and Mlplus	Acell, Inc.	FTM	Class II	2004-07-07
K041101	Medical Adhesiveonline, Llc. Iontophoresis Drug Delivery Electrodes, Models 23001, 23002, 23003, 23004, and 24001	Medical Adhesiveonline, LLC	EGJ	Class II	2004-07-07
K041020	Cadstream Version 3.1	Confirma, Inc.	LNH	Class II	2004-07-07
K041013	Suile Ointment Wound Dressing	Hedonist Biochemical Technologies Co., Ltd.	FRO	Unclassified	2004-07-07
K040988	Zircon-F Prophylaxis Paste	Pascal International, Inc.	EJR	Class I	2004-07-07
K040237	Intuitive Surgical Da Vinci Endoscopic Instrument Control System and Endoscopic Instruments	Intuitive Surgical, Inc.	NAY	Class II	2004-07-07
K040007	Interferential Stimulator, Model Bmls02-6	BioMedical Life Systems Inc.	LIH	Class II	2004-07-07
K033926	Hourglass Vertebral Body Spacer	Medtronic Sofamor Danek	MQP	Class II	2004-07-07
K033679	Copsios Bone Void Filler (Bvf)	Centerpulse Spine-Tech, Inc.	MQV	Class II	2004-07-07
K033488	Cmi Magnetocardiograph	Cmi Cardiomag Imaging, Inc.	DPS	Class II	2004-07-07
K031140	Waterlase	Biolase MG LLC	GEX	Class II	2004-07-07
K041670	Bis Pediatric Sensor	Aspect Medical Systems, Inc.	GXY	Class II	2004-07-06
K041561	Liquichek Whole Blood Volatiles Control	Bio-Rad	DIF	Class I	2004-07-06
K041241	Medley System with Bar Code Module, Model 8600	CareFusion 303, Inc	FRN	Class II	2004-07-06
K040935	Ebi Xfix Dfs System	Ebi, LLC	KTT	Class II	2004-07-06
K040693	Pts Panels Ldl Cholesterol Test Strips	Polymer Technology Systems	MRR	Class I	2004-07-06
K040459	Triage Profiler S.o.b. Controls and S.o.b. Calibration Verification Controls	Biosite Incorporated	JJY	Class I	2004-07-06
K033953	Optimesh 500E Cement Restrictor	Spineology, Inc.	JDK	Class II	2004-07-06
K032905	3Dknee Porous Coated Femoral Component	Encore Orthopedics, Inc.	MBH	Class II	2004-07-06
K041636	H&s-Conductivity Standard Solution	H & S Technical Services	FKH	Class II	2004-07-02
K041576	Sourcelink	C.R. Bard Inc	KXK	Class II	2004-07-02
K041558	Stockertir Purge Control (Apc) System	Stockert Instrumente GmbH	DTW	Class II	2004-07-02
K041552	Ge Vivid 7 Bt04	General Electric Co.	IYN	Class II	2004-07-02
K041424	Nxstage System One	NxStage Medical Inc	KDI	Class II	2004-07-02
K041416	Exac-Temp Foley Catheter and Clini-Temp Foley Catheter	Deroyal	EYC	Class II	2004-07-02
K041325	Disposable Colored Vinyl Synthetic Exam Glove, Powder Free	Est International Corporation	LYZ	Class I	2004-07-02
K041133	Modification to Bayer Advia Centaur Automated Chemiluminescence Analyzer	Medrad, Inc.	CDD	Class II	2004-07-02
K041043	Varelisa Pr3 Anca, Model Number 17748/17796	Pharmacia Deutschland GmbH	MOB	Class II	2004-07-02
K041004	Illusion Powder Free-Polymer Coated Color Scented Nr Latex Examination Gloves (Blue)	Purna Bina Sdn Bhd	LYY	Class I	2004-07-02