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 1911 of 3531

510(k) clearances, page 1911 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K970095	Proclear Compatibles Daily Wear Contact Lens	Biocompatibles Eyewear, Inc.	LPL	Class II	1997-04-03
K970074	Stanilet Freestanding/cc Infant/2000c Infant Warmer (1250C/1500c/2000d)	Hill-Rom Inc.	FMT	Class II	1997-04-03
K964970	Biomet Bone Screw	Zimmer GmbH	HWC	Class II	1997-04-03
K964083	Ultratherm (908)	Sie-Med, Inc.	IMJ	Class II	1997-04-03
K963855	12 Ureteroscopes/uretero-Renoscopes	Richard Wolf Medical Instruments Corp.	FGB	Class II	1997-04-03
K963616	Aloka Ssd-1700 Diagnostic Ultrasound System	Aloka Co., Ltd.	IYN	Class II	1997-04-03
K963503	Cts Midcab Coronary Shunt	Cardiothoracic Systems, Inc.	DXC	Class II	1997-04-03
K963330	Urodynamic Analysis Module	Synectics Medical, Inc.	FAP	Class II	1997-04-03
K962696	Perifix Pediatric Epidural Kit	B.Braun Medical, Inc.	CAZ	Class II	1997-04-03
K962627	Clinical Phosphorus Spectroscopy Option/magnetom Vision System	Siemens Medical Solutions USA, Inc.	LNI	Class II	1997-04-03
K961388	Atlas III Acetabular Cup	Fournitures Hospitalieres	MEH	Class II	1997-04-03
K970984	The Elecsys Calcheck Progesterone	Boehringer Mannheim Corp.	JJX	Class I	1997-04-02
K970979	Liquid Csf(lcr)1, Liquid Csf(lcr)2	Chiron Diagnostics Corp.	JJY	Class I	1997-04-02
K970976	Cardioimmune Cardiac Marker Control, Levels 1,2 and 3	Medical Analysis Systems, Inc.	JJY	Class I	1997-04-02
K970833	Indole Swab	Remel Inc	JTO	Class I	1997-04-02
K970831	Remel Sparfloxacin 5G Susceptibilty Disk	Remel Inc	JTN	Class II	1997-04-02
K970830	Remel Levofloxacin 5G Susceptibilty Disk	Remel Inc	JTN	Class II	1997-04-02
K970800	Maxcess Needlefree - Y- Site (100713)	Solopak Medical Products, Inc.	FPA	Class II	1997-04-02
K970733	Synthes Titanium Diastal Femoral Nail (Ti Dfn) System	Synthes (USA) Products LLC	HTY	Class II	1997-04-02
K970701	Dsl 1900 Active Human Growth Hormone Irma (Dsl 1900)	Diagnostic Systems Laboratories, Inc.	CFL	Class I	1997-04-02
K970637	Accucure 1000	Lasermed Corp.	GEX	Class II	1997-04-02
K970438	Interlink Micro-Infusion Manifold Extension Sets	Baxter Healthcare Corporation	FPA	Class II	1997-04-02
K970312	Controlled Process Release of Flexlens (Hefilcon a)	Flexlens, Inc.	LPL	Class II	1997-04-02
K970308	Mentor Urology Triple Rib Occlusion Wrap for Male Incontinence	Mentor Urology, Inc.	FHA	Class I	1997-04-02
K970271	Alexander Manufacturing Company	Alexander Mfg. Co.	FLL	Class II	1997-04-02
K970217	Vista Illumination System	Vista Medical Technologies, Inc.	FFS	Class II	1997-04-02
K970121	Stone Dislodger, Basket	Boston Scientific Corporation	FGO	Class II	1997-04-02
K970116	Esg-1 Electrosonogram (Esg-1)	Myo-Tronics, Inc.	NFQ	Class I	1997-04-02
K970113	Ultra-Blend Plus	Ultradent Products Inc.	EJK	Class II	1997-04-02
K970031	Foundation Knee System Tibial Component	Encore Orthopedics, Inc.	JWH	Class II	1997-04-02
K970029	Keeler Spectra Indirect Ophthalmoscope	Keeler Instruments, Inc.	HLJ	Class II	1997-04-02
K964989	Cdc Vial and Bag Access Pin (Cdc-P-1/P-2/P-3/P-4/P-5)	Critical Device Corp.	LHI	Class II	1997-04-02
K964654	Becton Dickinson Blunt Plastic Cannula	BD Becton Dickinson Vacutainer Systems Preanalytic	FMI	Class II	1997-04-02
K964435	Primary IV Set	Abbott Medical	FMG	Class II	1997-04-02
K964038	Charisma F, Charisma Creactive, Solid Bond, & Esticid -20Fg	Kulzer GmbH	KLE	Class II	1997-04-02
K963716	Mics Device System	Percutaneous Technologies	DXC	Class II	1997-04-02
K963631	Sleep Study Analysis (Ssa) Version 96.10	Omega Results	OLZ	Class II	1997-04-02
K963613	Immulite Rubella Igg	Siemens Healthcare Diagnostics Inc.	LFX	Class II	1997-04-02
K961260	Kirschner Sholders with Titanium Plasma Spray	Zimmer GmbH	HSD	Class II	1997-04-02
K954120	Model 9500 Mr-Compatible Multigas Monitor	Magnetic Resonance Equipment Corp.	CCK	Class II	1997-04-02
K953122	Steritec Dry Heat Indicator Label	Steritec Products Mfg. Co., Inc.	JOJ	Class II	1997-04-02
K952912	Spacelabs Medical Integrated Multi-Parameter Module	GE Healthcare	DSI	Class II	1997-04-02
K970975	Prostyle Intra	Planmeca Oy	EHD	Class II	1997-04-01
K970924	Regent Biogel Surgical Glove, Biogel M Glove	Regent Medical	KGO	Class I	1997-04-01
K970603	D Series Electrode	Cmc Sense-It, Inc.	DSB	Class II	1997-04-01
K970450	Upscan 120	Merlin Engineering Works, Inc.	LLZ	Class II	1997-04-01
K970434	Neo-Picc	Klein-Baker Medical, Inc.	LJS	Class II	1997-04-01
K970290	Ebi X Fix Dynafix Mini External Fixation System	Ebi, LLC	KTT	Class II	1997-04-01
K970035	John Bunn Neb-U-Lite II Medication Compressor with Disposable Nebulizer, Model #Jbo-112-009	Graham-Field, Inc.	CAF	Class II	1997-04-01
K970010	Fpt Nebulizer	Fluid Propulsion Technologies, Inc.	CAF	Class II	1997-04-01