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 1250 of 3531

510(k) clearances, page 1250 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K060972	Kedall 14.5 Fr Chronic Hemodialysis Catheter W/silver Impregnated Sleeve (Palindrome Ruby)	Kendall	MSD	Class II	2006-08-04
K060624	Marathon Stent with Fusion Technology	Cook Ireland Ltd.	FGE	Class II	2006-08-04
K060307	12 Rl Algorithm	GE Medical Systems Information Technologies, Inc.	DRT	Class II	2006-08-04
K060235	Endo-Ease Endoscopic Overtube	Spirus Medical, LLC	FDA	Class II	2006-08-04
K060010	Nautiflux	Sedat	DQO	Class II	2006-08-04
K053399	Versalet 7700 Care Center	Draeger Medical Infant Care, Inc.	FMZ	Class II	2006-08-04
K053348	Stryker Orthopaedics Rfid Instrumentation	Howmedica Osteonics Corp	HAW	Class II	2006-08-04
K062037	Triathlon Low Profile Tibial Tray	Howmedica Osteonics Corp	JWH	Class II	2006-08-03
K061986	1.9F X 20 Cm Vascu-Picc, Models Vp1.9s20 and Vp1.9s50	Medcomp	LJS	Class II	2006-08-03
K061836	Avs Asl Peek Spacer System	Howmedica Osteonics Corp	MQP	Class II	2006-08-03
K061492	Monoject Magellan Insulin and Tuberculin Safety Syringe	Tyco Healthcare	FMF	Class II	2006-08-03
K061383	Bti Sterile Dental Drills Kit, Bti Abutments and Caps	B.T.I. Biotechnology Institute, S.L.	EJL	Class I	2006-08-03
K061230	Vectors Temporary Anchorage System	Sybron Dental Specialties, Inc.	OAT	Class II	2006-08-03
K061165	Elia Ccp, Model 14-5515-01; Elia Ccp Control, Model 83-1009-01	Sweden Diagnostics (Us), Inc.	NHX	Class II	2006-08-03
K061015	Fast-Cath Hemostasis Introducer and Transseptal Introducer	Abbott Medical	DYB	Class II	2006-08-03
K060474	Lisfranc Plate	New Deal, S.A.	HRS	Class II	2006-08-03
K062057	U-Clip Device, Model Nc65	Medtronic, Inc.	FZP	Class II	2006-08-02
K061822	Omron Automatic Blood Pressure Monitor with Comfit Cuff, Model Hem 780 N3	Omron Healthcare Co., Ltd.	DXN	Class II	2006-08-02
K061722	Bloxx Rapid Clotting Agent	Crosslink-D, Inc.	QSY	Unclassified	2006-08-02
K061703	Dimension Vista Chemistry 2 Calibrator (Chem 2 Cal, Kc120)	Siemens Healthcare Diagnostics Inc.	JIX	Class II	2006-08-02
K061675	Vision Vxc Central Station, Model 4300	Invivo Corporation	MHX	Class II	2006-08-02
K061565	Langston Dual Lumen Catheter	Vascular Solutions LLC	DQO	Class II	2006-08-02
K061344	Excia Total Hip System Lateral Offset	Aesculap Inc	JDI	Class II	2006-08-02
K061256	Smartmonitor 2Ps	Respironics, Inc.	NPF	Class II	2006-08-02
K061226	Trabecular Metal Acetabular Revision System Cage	Zimmer GmbH	LPH	Class II	2006-08-02
K060297	Peper	Medical Monitors, Inc.	DXH	Class II	2006-08-02
K053041	Med Sculpt	General Project S.r.l.	IMI	Class II	2006-08-02
K050842	Agcel Wound Dressing,agcel Burn Dressing	Modern Medical Equipment Mfg., Ltd.	FRO	Unclassified	2006-08-02
K061912	Fusion	Burke, Inc.	INI	Class II	2006-08-01
K061882	Oxygenless Packaging Conversion of Legacy Centerpulse Standard Polyethylene Devices	Zimmer GmbH	JWH	Class II	2006-08-01
K061857	Model Multi-Flo Ic-1545-Kt/-F Intermittent Circulator	Bio Compression Systems, Inc.	JOW	Class II	2006-08-01
K061843	Venture Wire Control Catheter, Model Wcc	Abbott Medical	DQY	Class II	2006-08-01
K061762	Tiburon Drape, Model 9349N/ Optima Drape, Model 9446N	Medtronic, Inc.	KKX	Class II	2006-08-01
K061522	Trivarion Buffered Iontophoresis Electrode System	Activatek, Inc.	EGJ	Class II	2006-08-01
K061513	Level 1 Snuggle Warm Pediatric and Large Pediatric Underbody Blanket	Abbott Medical	DWJ	Class II	2006-08-01
K061486	Tampax Tampons - (Light,regular,super and Super Plus Absorbencies)	Procter & Gamble Co.	HEB	Class II	2006-08-01
K061455	Dornier Medilas H 20 Laser	Dornier Medtech America, Inc.	GEX	Class II	2006-08-01
K061392	Ikoniscope Fastfish Auto/amniocyte Test System	Ikonisys, Inc.	JOY	Class II	2006-08-01
K061373	Vnus Closurefast Catheter, Models Cf7-7-60 and Cf7-7-100	Vnus Medical Technologies, Inc.	GEI	Class II	2006-08-01
K060833	12Sl ECG Analysis Program	GE Medical Systems Information Technologies, Inc.	MHX	Class II	2006-08-01
K053092	Medcomp Vascu-Sheath II	Medcomp	DYB	Class II	2006-08-01
K062052	Lmt Nomag Ic 3.0	Lmt Lammers Medical Technology GmbH	FPL	Class II	2006-07-31
K062050	Flexview System	Boston Scientific Corporation	GCJ	Class II	2006-07-31
K061981	Surpass	Apex Dental Materials, Inc.	KLE	Class II	2006-07-31
K061837	Nxstage Cartridge Express	NxStage Medical Inc	KDI	Class II	2006-07-31
K061807	Spi Art Abutments	Thommen Medical AG	NHA	Class II	2006-07-31
K061424	Celsite/ Celsite Concept, Access Ports	Aesculap Inc	LJT	Class II	2006-07-31
K061374	Intuition Infusion Sets	Unomedical A/S	FPA	Class II	2006-07-31
K061268	G-Lix Tissue Grasper	Usgi Medical	HET	Class II	2006-07-31
K061266	Ortho Organizers Temporary Orthodontic Anchor	Ortho Organizers Inc	OAT	Class II	2006-07-31