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 2026-10-26, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,069 of the 176,466 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	2,669

176,466 records, page 739 of 3530

510(k) clearances, page 739 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K141810	Bd Bactec Plus Anaerobic/f (Plastic)	Becton Dickinson & Co	MDB	Class I	2014-12-10
K141463	Liason Xl1,25 Dihydroxyvitamin D; Control Set, Calibration Verifiers	Diasorin Inc.	MRG	Class II	2014-12-10
K141213	Ameriwater Ozone Disinfection System	AmeriWater LLC.	FIN	Class II	2014-12-10
K141054	Distal Access Torque Device	Distal Access, LLC	DQX	Class II	2014-12-10
K140624	Hicura Hand Instruments	Olympus Winter & Ibe GmbH	GEI	Class II	2014-12-10
K133218	Crystal ®; Mosaic ®; Vertu ®	Spinal Elements, Inc	OVE	Class II	2014-12-10
K143264	H60 V2.00 Diagnostic Ultrasound System	Samsung Medison Co., Ltd.	IYN	Class II	2014-12-09
K143208	Denali Filter System - Femoral Delivery Kit, Denali Filter System - Jugular/Subclavain Delivery Kit	C.R. Bard Inc	DTK	Class II	2014-12-09
K142547	Bluntport Blunt Trocar with Threaded Anchor 5mm-12mm	Medtronic, Inc.	GCJ	Class II	2014-12-09
K142126	Ep Navigator Rel. 5.0	Philips Medical Systems Nederland B.V.	OWB	Class II	2014-12-09
K141925	Total Protein Urine/csf Gen.3	Roche Diagnostics Operations (Rdo)	JIQ	Class I	2014-12-09
K140224	Euroimmun Euroline Ena Profile 9Ag (Igg)	Euroimmun US Inc.	LKO	Class II	2014-12-09
K142433	Hospira Extension Set	Abbott Medical	FPA	Class II	2014-12-08
K142264	Valeo C Spacer System, Valeo II C IBF Device	Amedica Corp.	ODP	Class II	2014-12-08
K141795	Batter Pack, Replacement for Physio Control Lifepak 500	R & D Batteries, Inc.	MKJ	Class III	2014-12-08
K141760	Orthofix Galaxy Wrist	Orthofix SRL	KTT	Class II	2014-12-08
K141557	Herniatome Percutaneous Disectomy Device - Cervical, Herniatome Percutaneous Disectomy Device - Lumbar	Gallini Medical Devices, SRL	HRX	Class II	2014-12-08
K141507	Two Skin Treatment System	Syneron Medical, Ltd.	GEI	Class II	2014-12-08
K140971	Liquid Assayed Chemistry Control Premium Plus Level 1,2 and Level 3.	Randox Laboratories, Limited	JJY	Class I	2014-12-08
K140665	GenPrime Snap-Top Split Key Cup	Genprime, Inc.	DIS	Class II	2014-12-08
K143221	Schoelly Laparoscope	Schoelly Fiberoptic, GmbH	GCJ	Class II	2014-12-05
K143205	Viscoelastic Injector	Sight Sciences, Inc.	MRH	Class II	2014-12-05
K143194	ADIVA Centaur Prolactin Master Curve Material (MCM), ADIVA Centaur Cortisol Master Curve Material (MCM)	Siemens Healthcare Diagnostics Inc.	JJX	Class I	2014-12-05
K143025	Total Compression Plating System	Wrightmedicaltechnologyinc	HRS	Class II	2014-12-05
K142758	ADVIA Centaur HAV total assay	Siemens Healthcare Diagnostics Inc.	LOL	Class II	2014-12-05
K142676	Siemens 3.0T PROCURE Array Coil	Resonance Innovations, LLC	MOS	Class II	2014-12-05
K142671	Onefit Hip Planner	Onefit Medical	LLZ	Class II	2014-12-05
K142431	WaterProof PROFILER	Sun Nuclear Corporation	IYE	Class II	2014-12-05
K142409	Vinyl Co-Polymer Powder Free Examination Gloves	Grand Work Plastic Products Co., Ltd.	LYZ	Class I	2014-12-05
K142388	Neo Total Knee System	New Era Orthopedics, LLC	JWH	Class II	2014-12-05
K142379	Passeo-35 PTA Catheter	BIOTRONIK AG	LIT	Class II	2014-12-05
K142365	Simplexa Flu A/B & RSV Direct & Simplexa Flu A/B RSV Positive Control Pack	DiaSorin Molecular LLC	OCC	Class II	2014-12-05
K142361	Discovery MR750 3.0T	GE Healthcare	LNH	Class II	2014-12-05
K142142	Quality Reports	Sun Nuclear Corporation	IYE	Class II	2014-12-05
K142052	Orthofix Galaxy Unyco Diaphyseal Tibia Kit	Orthofix SRL	KTT	Class II	2014-12-05
K141964	Xn Check	Streck LLC	JPK	Class II	2014-12-05
K141962	Xn Cal	Streck LLC	KRX	Class II	2014-12-05
K141957	Xn Check Bf	Streck LLC	JPK	Class II	2014-12-05
K141955	Xn Cal Pf	Streck LLC	KRX	Class II	2014-12-05
K141701	I-125 Rsln [Radioactive Seed and Localization Needle]	Isoaid, L.L.C.	KXK	Class II	2014-12-05
K141681	Sysmex Xn Series	Sysmex America, Inc.	GKZ	Class II	2014-12-05
K141611	Lythos Digital Impression System	Ormco Corp.	NOF	Class II	2014-12-05
K140931	Igrow II Hair Growth System	Apira Science, Inc.	OAP	Class II	2014-12-05
K140847	Cardiospy ECG Holter Systems	Labtech Kft.	MLO	Class II	2014-12-05
K140838	IV Administration Set with Hand Pump	B.Braun Medical, Inc.	FPA	Class II	2014-12-05
K140705	Navigable Brain Biopsy Cannula Set	Izi Medical Products LLC	HAW	Class II	2014-12-05
K132313	Pessary	Eis Corporation	HHW	Class II	2014-12-05
K143145	SafeAir Smoke Pencil	LiNA Medical Inc	GEI	Class II	2014-12-04
K143079	Endovascular Stent Planning Software	Canon Medical Informatics, Inc.	LLZ	Class II	2014-12-04
K142728	ActiveCare+SFT; ActiveCare+SFT HomeCare (ActiveCare+SFT-sub-category), ActiveCare+DTx ; ActiveCare+DTx HomeCare (ActiveCare+DTx-sub-category)	Medical Compressions System (Dbn), Ltd.	JOW	Class II	2014-12-04