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 2026-10-29, 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 810 of 3530

510(k) clearances, page 810 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K132188	Mammography Viewer Smv658	FUJIFILM Healthcare Americas Corporation	LLZ	Class II	2013-10-25
K132059	Diagnostic Ultrasound System	Advanced Instrumentations, Inc.	IYN	Class II	2013-10-25
K132020	Advance 34Lp Low Profile Pta Balloon Dilatation Catheter	Cook Inc.	LIT	Class II	2013-10-25
K131162	Miradry System	miraDry, Inc.	OUB	Class II	2013-10-25
K131058	Bipolar Forceps	Boston Endo-Surgical Technologies, Inc.	GEI	Class II	2013-10-25
K130999	Osseospeed Profile Ev	Dentsply Implants Manufacturing GmbH	DZE	Class II	2013-10-25
K130904	Trellis-8 Peripheral Infusion System	Medtronic, Inc.	QEY	Class II	2013-10-25
K130866	Biolight Biodynam	Biolight AB	ILY	Class II	2013-10-25
K130529	Raumedic-Pto-Monitoring-System	Raumedic AG	GWM	Class II	2013-10-25
K130459	Tria Fan System	Tria Beauty, Inc.	ONG	Class II	2013-10-25
K130428	Covamesh	Dilon Technologies France SAS	FTL	Class II	2013-10-25
K123713	Immulisa Enhanced Celiac Fusion (Ttg/dgp) Iga/igg Antibody Elisa	Immco Diagnostics, Inc.	MVM	Class II	2013-10-25
K123696	Medusa Vascular Plug	Endoshape, Inc.	KRD	Class II	2013-10-25
K133003	Rightest Control Solution	Bionime Corporation	JJX	Class I	2013-10-24
K132804	Acuson S1000 / S2000 / S3000	Siemens Medical Solutions USA, Inc. Ultrasound Gro	IYN	Class II	2013-10-24
K132556	Sheathless Eaucath Coronary Guide Catheter	Asahi Intecc Co., Ltd.	DQY	Class II	2013-10-24
K132512	Harmonic Ace Curved Shears with Scissor Handle, Harmonic Ace Curved Shears with Ergonomic Handle	Ethicon Endo-Surgery Inc	LFL	Unclassified	2013-10-24
K132510	Biopro - Infinity Plate Anchor System	Biopro, Inc.	HTN	Class II	2013-10-24
K132338	Da01 Blood Glucose Monitoring System	Delbio Incorporation	NBW	Class II	2013-10-24
K132255	Ultracem	Ultradent Products Inc. / Oratech, LLC	EMA	Class II	2013-10-24
K131895	Airvo 2 Humidifier, Myairvo 2 Humidifier	Fisher & Paykel Healthcare, Inc.	BTT	Class II	2013-10-24
K131887	Trojan Jaguar Male Natural Rubber Latex Condom with Warming and Tingling Lubricant	Church & Dwight Co., Inc.	HIS	Class II	2013-10-24
K131881	Ombra Table Top Compressor	Trudell Medical Intl.	BTI	Class II	2013-10-24
K131473	(Quanta System) Surgical Laser Fibers	Quanta System Inc.	GEX	Class II	2013-10-24
K131427	Lotus	Spinal Elements, Inc	KWP	Class II	2013-10-24
K131393	Mak Oss Femoral Knee Components	Biomet Orthopedics, Inc.	KRO	Class II	2013-10-24
K122295	Core 3D Abutment System for Digital Prosthetic Solutions	Core 3D Protech, S.L.	NHA	Class II	2013-10-24
K132895	Wmt Implantable K-Wire	Wrightmedicaltechnologyinc	HTY	Class II	2013-10-23
K132627	Automatic Digital Blood Pressure Monitor	HONSUN (NANTONG) Co., Ltd.	DXN	Class II	2013-10-23
K132502	Variax 2 System	Stryker Trauma GmbH	HRS	Class II	2013-10-23
K132493	Endo Gia Radial Reload with Tri-Staple Technology	Medtronic, Inc.	GDW	Class II	2013-10-23
K132446	Renasys Ez Max Negative Pressure Wound Therapy Device	Smith & Nephew, Inc.	OMP	Class II	2013-10-23
K132343	Marigen Wound Dressing	Kerecis Limited	KGN	Unclassified	2013-10-23
K132156	Randox Csf Controls Levels 2 and 3	Randox Laboratories, Limited	JJY	Class I	2013-10-23
K131679	Evolution Mp Adaptive Ps Tibial Insert	Wrightmedicaltechnologyinc	JWH	Class II	2013-10-23
K131590	Innersense Esophageal Temperature Probe / Feeding Tube	Philips North America LLC	FPD	Class II	2013-10-23
K131530	Dynamesh -Cicat	Feg Textiltechnik Forschungs-Und Entwicklungsgesel	FTL	Class II	2013-10-23
K131350	Calix Lumbar Spinal Implant System	Xtant Medical Holdings, Inc.	MAX	Class II	2013-10-23
K130971	Optum Telehealth Application	Optum Distribution Center, LLC	DRG	Class II	2013-10-23
K133128	Immulite 2000; Hcg Calibration Verification Material, Insulin Calibration Verification Material, Pyrilinks-D Calibration	Siemens Healthcare Diagnostics Inc.	JJX	Class I	2013-10-22
K132990	Occlusion Balloon Catheter	Boston Scientific Corporation	MJN	Class II	2013-10-22
K132751	Multichem S Plus / S Plus (Assayed)	Techno-Path Manufacturing Ltd.	JJY	Class I	2013-10-22
K132727	Gem Flow Coupler Device and System	Synovis Life Technologies, Inc.	MVR	Class II	2013-10-22
K132673	5F & 6F Launcher Guide Catheter, 5F Sherpa Active Nx Guide Catheter, 6F Z4 Guiding Catheter	Medtronic, Inc.	DQY	Class II	2013-10-22
K132494	Viscoelastic Injector	Sight Sciences, Inc.	MRH	Class II	2013-10-22
K132435	Smith & Nephew Global Femoral Head Trials	Smith & Nephew, Inc.	LZO	Class II	2013-10-22
K131963	Tautona Injector Device	Tautona Group	FMF	Class II	2013-10-22
K131253	Periflux 6000	Perimed AB	LKD	Class II	2013-10-22
K131187	Lesser Metatarsal Head Implant System	Solana Surgical, LLC	KWD	Class II	2013-10-22
K131157	Ranfac Bone Marrow Aspiration Needle	Ranfac Corp.	KNW	Class II	2013-10-22