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 1969 of 3531

510(k) clearances, page 1969 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K960430	Control Syringe	Scientific Device Manufacturer, LLC	DXT	Class II	1996-08-06
K960297	Mandibular Bone Distractor II	Howmedica Corp.	MQN	Class II	1996-08-06
K955865	Bear Cub Infant Pressure Ventilator	Allied Medical LLC	CBK	Class II	1996-08-06
K952927	Impact Air 45 4-Hole	Palisades Pharmaceutics, Inc.	EFB	Class I	1996-08-06
K962367	Olympus Basket Graspers	OLYMPUS Corporation of the Americas	EOQ	Class II	1996-08-05
K962022	Powercut Gold Surgical System	Baxter Healthcare Corporation	HWE	Class I	1996-08-05
K962011	Synthes 7.0/7.3 Mm Cannulated Screws	Synthes (USA) Products LLC	HWC	Class II	1996-08-05
K961921	Apr Oversized Hip Stem	Intermedics Orthopedics	LZO	Class II	1996-08-05
K961571	Cocr Bi-Angular Humeral Component	Zimmer GmbH	KWT	Class II	1996-08-05
K961477	Triglycerides - Incorporating Dynamic Stabilization Technology	Trace America, Inc.	CDT	Class I	1996-08-05
K960588	Wagner Revision Stem	Intermedics Orthopedics	LZO	Class II	1996-08-05
K960574	Argyle Turkel Neonatal/pediatric Thoracic Catheter Insertion Tray and Thoracic Catheter System	Sherwood Medical Co.	FHO	Class II	1996-08-05
K960318	Dib Infusor-Ra	Novacon Corp.	MEB	Class II	1996-08-05
K955897	Crypto/giardia-Cel If Test	Techlab, Inc.	MHI	Class II	1996-08-05
K955852	Crypto-Cel If Test	Techlab, Inc.	MHJ	Class II	1996-08-05
K955849	Dib Infusor	Novacon Corp.	MEB	Class II	1996-08-05
K954861	Brainlab Ct/x-Ray Localizer	Brainlab Med. Computersysteme GmbH	IYE	Class II	1996-08-05
K952244	Cross-Checks Eo Gas Sterilization Monitor	Steritec Products Mfg. Co., Inc.	JOJ	Class II	1996-08-05
K950809	Vision-Sciences Disposable Endosheath for Flexible Nasopharyngo-Laryngoscopes	Cogentix Medical, Inc.	EOB	Class II	1996-08-05
K962480	Coated Vicryl Rapide (Polyglactin 910) Braided, Synthetic Absorbable Suture, Undyed	Ethicon, Inc	GAM	Class II	1996-08-02
K962423	Bblcrystal Neisseria/haemophilus (N/h) System	Becton Dickinson Microbiology Systems	JST	Class I	1996-08-02
K962399	Hepatitis Negative Control	Pyramid Biological Corp.	MJY	Class I	1996-08-02
K962378	Olympus Fg-45/46-1 Grasping Forceps	OLYMPUS Corporation of the Americas	EOQ	Class II	1996-08-02
K962352	Hydrogel Skin Dressing	North American Sterilization & Packaging Co.	NAE	Class I	1996-08-02
K962137	Genesis II Constrained System	Smith & Nephew Richards, Inc.	JWH	Class II	1996-08-02
K962125	Technicon Immuno 1 System	Bayer Corp.	JJE	Class I	1996-08-02
K961842	Software Version 8.5Cd of the Mrt-35A Magnetic Resonance Imaging System	Toshiba America Mri, Inc.	LNH	Class II	1996-08-02
K961770	Philips 71 Series	Philips Hearing Instruments Co.	ESD	Class I	1996-08-02
K961183	Cbi 7520 Reader	Columbia Bioscience, Inc.	JJQ	Class I	1996-08-02
K960075	Chromagar Candida	Hardy Diagnostics	JXC	Class I	1996-08-02
K960044	Ultramax/model Number A1	Entlab Oy	LWI	Class II	1996-08-02
K955760	Toxoplasma Igg in-Vitro Diagnostic System	Bayer Corp.	LGD	Class II	1996-08-02
K962786	Osteograf Stainless Steel Syring	Ceramed Corp.	LYC	Class II	1996-08-01
K962770	Urosurge Acutrainer	Princeton Regulatory Assoc.	KPN	Class II	1996-08-01
K962527	General Purpose Dental Tray	Medcare Medical Group, Inc.	EIA	Class I	1996-08-01
K962515	Kerr Advanced Adhesive	Kerr Dental Materials Center	KLE	Class II	1996-08-01
K962181	Hare Model 2000 Ez Loader Model 95555	Dyna Corp.	FPO	Class II	1996-08-01
K962133	Expandacell Injecto-Pak	Summit Medical, LLC	EMX	Class I	1996-08-01
K962007	Protrusion Cages	Depuy, Inc.	JDJ	Class II	1996-08-01
K961916	Hoffmann II Carbon Connecting Rod	Howmedica Corp.	JEC	Class II	1996-08-01
K961899	Cps, Cemented Hip System	Artos Medical Products GmbH	JDI	Class II	1996-08-01
K961884	Cath Caddie	Mark-Clark	KNT	Class II	1996-08-01
K961794	Fluid Administration Set - Contrast Manager	Merit Medical Systems, Inc.	FPA	Class II	1996-08-01
K961789	Resorbable Soft Tissue Attachment Device	Zimmer GmbH	MAI	Class II	1996-08-01
K961783	Sullivan Vpap II St Nasal Vpap System	ResMed Corp	BZD	Class II	1996-08-01
K961725	Oscar Orthosonics System for Cemented Arthroplasty Revision	C.L. Mcintosh & Assoc., Inc.	JDX	Class II	1996-08-01
K961450	Score Software	Medtronic, Inc.	DQA	Class II	1996-08-01
K961444	Global Medical Combined Spinal Epidural Kit (Gma 1827 and Gma 1725)	Global Medical Products, Ltd.	BSP	Class II	1996-08-01
K960886	Steri-Oss 6 Mm Diameter Ha Coated Implants	Steri-Oss, Inc.	DZE	Class II	1996-08-01
K960417	3I Stnd Threaded/self Tapping Threaded/3i Miniplant Implants/3 I Emergence Prof. Temp. Healing Abutments	ZimVie US Corp LLC	DZE	Class II	1996-08-01