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 764 of 3530

510(k) clearances, page 764 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K133551	Zimmer Zfx Titanium Base Abutment for Tapered Screwvent Implant System	ZimVie US Corp LLC	NHA	Class II	2014-07-18
K133233	Pjur Original, Pjur Woman, Pjur Man Extreme Glide	pjur group Luxembourg S.A.	NUC	Class II	2014-07-18
K132732	Medyssey Anterior Cervical Fusion Cage	Medyssey USA	ODP	Class II	2014-07-18
K141647	Healgen Coc One Step Cocaine Test Strip:morhpine Test Strip (Cassette, Cup, Dip Card)	Healgen Scientific LLC	DIO	Class II	2014-07-17
K141143	Cobas C Tina-Quant Cystatin C Gen.2 Assay, C.f.a.s. Cystatin C Calibrator, Cystatin C Gen.2 Control Set	Roche Diagnostics GmbH	NDY	Class II	2014-07-17
K140903	Nuvis Arthroscope	Integrated Endoscopy, Inc.	HRX	Class II	2014-07-17
K140825	Delworks Dr System	Del Medical, Inc.	MQB	Class II	2014-07-17
K140757	D2 Hemostantic Dressing	Z-Medica, LLC	QSY	Unclassified	2014-07-17
K140750	Shilla Growth Guidance System	Medtronic Sofamor Danek USA Inc	PGM	Class II	2014-07-17
K140682	Fingertip Pulse Oximeter	Beijing Choice Electronic Technololgy Co., Ltd.	DQA	Class II	2014-07-17
K140515	Verify Hpu Chemical Indicator/ Verify Vaporized Vh202 Process Indicator Adhesive Label	STERIS Corporation	JOJ	Class II	2014-07-17
K140504	Accucath Bc Intravascular Catheter System	Vascular Pathways, Inc.	FOZ	Class II	2014-07-17
K140499	Verify V24 Self-Contained Biological Indicator for Vaporized Vh202 Sterilization Processes	STERIS Corporation	FRC	Class II	2014-07-17
K131757	Tattoostar Effect Combo	Asclepion Laser Technologies GmbH	GEX	Class II	2014-07-17
K141566	Solid State X-Ray Imaging Device, Digiital Flat Panel X-Ray Detector, 1417Wcc	Rayence Co., Ltd.	MQB	Class II	2014-07-16
K141563	Solid State X-Ray Imaging Device, Digital Flat Panel X-Ray Detector, 1417Wgc	Rayence Co., Ltd.	MQB	Class II	2014-07-16
K141217	Acculif Tl and Pl Cage	Stryker Corp.	MAX	Class II	2014-07-16
K141112	Sterling Over-the Wire Pta Balloon Dilatation Catheter	Boston Scientific Corporation	LIT	Class II	2014-07-16
K141000	Sensititre Susceptibility Plates	Thermo Fisher Scientific Oy	JWY	Class II	2014-07-16
K140844	Biosphere Bioactive Bone Graft Putty, 2.5Cc, 5Cc, 10Cc	Synergy Biomedical	MQV	Class II	2014-07-16
K140714	Porcine Anorganic Bone Mineral	Collagen Matrix, Inc	NPM	Class II	2014-07-16
K140558	Proctigard	Access Pharmaceuticals, Inc.	PHN	Unclassified	2014-07-16
K140142	Choice Spine Lumbar Spacer System (Sabre, Shark, Hornet, Harpoon)	Choicespine, LP	MAX	Class II	2014-07-16
K133568	G-Tl	Vitrolife Inc.	MQL	Class II	2014-07-16
K141609	Pulstar Logix Pump	Albahealth, LLC	JOW	Class II	2014-07-15
K141063	Linscan 808, Linscan 980	Gme German Medical Engineering GmbH	GEX	Class II	2014-07-15
K140826	Gmk Sphere Extension	Medacta International SA	JWH	Class II	2014-07-15
K140813	Reprocessed Kendall Scd Express Compression Sleeves	Medtronic, Inc.	JOW	Class II	2014-07-15
K140789	Cormatrix Ecm for Vascular Repair	Cormatrix Cardiovascular, Inc.	DXZ	Class II	2014-07-15
K140753	Endo Smart Bottle, Rinse and Insufflation System	Medivators Inc	OCX	Class II	2014-07-15
K140615	Victus Femtosecond Laser Platform	Technolas Perfect Vision GmbH	OOE	Class II	2014-07-15
K133890	Aesculap Optilene Nonabsorbable Suture	Aesculap Inc	GAW	Class II	2014-07-15
K133813	Flxfit Intervertebral Body Fusion Device	Expanding Orthopedics, Inc.	MAX	Class II	2014-07-15
K133053	Milestone Spinal System	Weigao Orthopaedic Device Co., Ltd.	MAX	Class II	2014-07-15
K132856	Heartway Power Wheelchair	Heartway Medical Products Co., Ltd.	ITI	Class II	2014-07-15
K141605	Cd Horizon Spinal System	Medtronic Sofamor Danek USA Inc	NKB	Class II	2014-07-14
K141532	Cr3 Keyless Split Sample Cup Amphetamine-Cocaine	Guangzhou Wondfo Biotech Co., Ltd.	DKZ	Class II	2014-07-14
K140829	Unicel Dxc Synchron Systems Hemoglobin A1c3 (Hba1c3) Reagent	Siemens Healthcare Diagnostics Inc.	LCP	Class II	2014-07-14
K133919	Consensus Vitalite Tibial Insert	Consensus Orthopedics, Inc.	JWH	Class II	2014-07-14
K132765	Pfx Spinous Process Fixation System	Innovasis, Inc	PEK	Class II	2014-07-14
K141582	Cp150 Electrocardiograph with Spirometry Option	Welch Allyn Inc	DPS	Class II	2014-07-11
K141558	Quill Monoderm Knotless Tissue-Closure Device	Surgical Specialties Corp	GAM	Class II	2014-07-11
K141554	Esie Apps Suite	Siemens Medical Solutions USA, Inc.	LLZ	Class II	2014-07-11
K141550	Instafix Shape Memory Fixation System	OT Medical GmbH	JDR	Class II	2014-07-11
K141486	Mylabsix Ultrasound System	Esaote Europe B.V.	IYN	Class II	2014-07-11
K141388	System Calibrater	Beckman Coulter Ireland Inc	JIX	Class II	2014-07-11
K141368	Neuropace Burr Hole Cover	Neuropace	GXR	Class II	2014-07-11
K141334	Reusable Guide	Koelis	ITX	Class II	2014-07-11
K141301	Maxlock Extreme Elbow Fracture System	TORNIER Inc.	HRS	Class II	2014-07-11
K140998	Pediatric 16, A1.5t Tim Coil/pediatric 16, A3t Tim Coil	Quality Electrodynamics	MOS	Class II	2014-07-11