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 849 of 3530

510(k) clearances, page 849 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K113042	Revois Implant System	Riemser Arzneimittel AG	DZE	Class II	2013-03-08
K130283	Evrf System	F Care Systems NV	ONQ	Class II	2013-03-07
K124039	Hero Graft	Hemoshpere, Inc., A Cryolife Company	DSY	Class II	2013-03-07
K124007	Silverspeed Hydrophilic Guidewire, X-Celerator Hydrophilic Exchange Guidewire, X-Pedion Hydrophilic Guidewire, Mirage Hy	Micro Therapeutics, Inc. D/B/A: Ev3, Inc.	DQX	Class II	2013-03-07
K123694	Sam Junctional Tourniquet	Sam Medical Products	DXC	Class II	2013-03-07
K123677	Dimension Vista; Ammonia Flex Reagent Cartridge (Amm), Chemistry 3 Calibrator (Chem 3 Cal)	Siemens Healthcare Diagnostics Inc.	JIF	Class I	2013-03-07
K123554	Shuntcheck	Neurodx Development, LLC	JXG	Class II	2013-03-07
K123411	Little Angels Swaddling Blanket	Bionix Development Corp.	PDH	Class II	2013-03-07
K123395	Nxstage System One Low Volume Cartridge Express	NxStage Medical Inc	KDI	Class II	2013-03-07
K123350	Eclipse Soft Tissue Fastener	Medshape, Inc.	MBI	Class II	2013-03-07
K123344	K-Shield Advantage Port Access Infusion Set (Pais)	Kawasumi Laboratories Co., Ltd.	FPA	Class II	2013-03-07
K123136	Genesis Health Record System, (Ghrs)	Genesis Health Technologies	NBW	Class II	2013-03-07
K123081	Bonos R Genta 1X20 Model 01-0228; Bonos R Genta 2X20 Model 01-0229; Bonos R Genta 1X40 Model 01-0217; Bonos R Genta 2X40	Aap Biomaterials GmbH & Co. KG	LOD	Class II	2013-03-07
K122476	Lifestyles Smooth 2-in-1 Massage & Lubricant	Ansell Healthcare Products LLC	NUC	Class II	2013-03-07
K121511	Maclin Power Intravascular Administration Set	Maclin Power Inc.	FPA	Class II	2013-03-07
K123373	Nautilus Spinal System	Life Spine	NKB	Class II	2013-03-06
K122847	Kangaroo Nasal Mask	Respironics, Inc.	BZD	Class II	2013-03-06
K122513	Cleared Under Grafton II Edbm	Medtronic Sofamor Danek	MBP	Class II	2013-03-06
K120815	Innersense Esophageal Temperature/feeding Tube	Philips North America LLC	FPD	Class II	2013-03-06
K130116	Superior Lateral Variax Clavicle Plate	Stryker Trauma GmbH	HRS	Class II	2013-03-05
K123993	Solus Anterior Lumbar Interbody Fusion (Alif) System	Alphatec Spine, Inc.	OVD	Class II	2013-03-05
K123980	Sonicone Plus Ultrasound Wound Care System and Accessories	Misonix, LLC	NRB	Class II	2013-03-05
K123914	Restorelle Y Contour	MEDLINE INDUSTRIES, LP - Northfield	OTO	Class II	2013-03-05
K123837	Pentaray Nav Eco High-Density Mapping Catheter	Biosense Webster Inc	MTD	Class II	2013-03-05
K123819	Multiple Name	Top Calibre Sdn Bhd	LYY	Class I	2013-03-05
K123472	Cimva Universal	Therapeutic Monitoring Systems (Tms), Inc.	MHX	Class II	2013-03-05
K123464	Callisto Eye	Carl Zeiss Meditec Inc	NFJ	Class II	2013-03-05
K123449	Biomonde Larvae	Biomonde (A Trading Name of Zoobiotic Limited)	NQK	Unclassified	2013-03-05
K123356	Fortiva Porcine Dermis	RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)	FTM	Class II	2013-03-05
K122986	Vidas Lyme Igg	bioMerieux, Inc.	LSR	Class II	2013-03-05
K121769	Dentocore / Dentocore Body	Itena Clinical	EBF	Class II	2013-03-05
K121488	Jms Safe Wing Cath (Swc)	JMS North America Corp.	FOZ	Class II	2013-03-05
K120740	Cols® Fixation System	Fournitures Hospitalieres Industrie	MBI	Class II	2013-03-05
K113717	Ultrasonic Scaler	Nakanishi Inc.	ELC	Class II	2013-03-05
K130307	Oncozene Microspheres 40Um, 2Ml, Oncozene Microspheres 75Um, 2Ml, Oncozene Microspheres 100Um, 2Ml, Oncozene Microsphere	Celonova Biosciences, Inc.	KRD	Class II	2013-03-04
K123893	Cura Collimator	Cura Medical Technologies, LLC	IXI	Class II	2013-03-04
K123889	Acleara, Theraclear	Theravant Corporation	ONF	Class II	2013-03-04
K123818	Ursa Angiographic Catheter	Curative Medical Technology, Inc.	DQO	Class II	2013-03-04
K123717	Ucentum	Ulrich GmbH & Co. KG	NKB	Class II	2013-03-04
K123392	Avenir Muller Stem	Zimmer GmbH	LZO	Class II	2013-03-04
K123188	Dornoch Duo Suction Cart with Dl2800 Lid Model Ul-Du2800, Dornoch Duo Suction Cart with Cl500 Lid Model Ul-Du500, Dornoc	Dornoch Medical Systems	JCX	Class II	2013-03-04
K123059	Inbone ( I and II) Total Ankle Systems	Wrightmedicaltechnologyinc	HSN	Class II	2013-03-04
K130262	Magnetom Essenza with Syngo Mr D14	Siemens Medical Solutions USA, Inc.	LNH	Class II	2013-03-01
K130245	Large Bore Stopcock with Rotating Male Luer Lock/large Bore Stopcock with Extension Set, Gang Large Bore Stopcock Manifo	Baxter Healthcare Corporation	FMG	Class II	2013-03-01
K130243	Ilab Ultrasound Imaging System	Boston Scientific Corporation	IYO	Class II	2013-03-01
K130162	Liquid Assayed Multiqual Premium	Bio-Rad Laboratories Inc.	JJY	Class I	2013-03-01
K130155	Muse Cardiology Information System	GE Medical Systems Information Technologies, Inc.	DQK	Class II	2013-03-01
K123924	Depuy Gription Tf 5.5Mm Sterile Locking Screws	Depuy Orthopaedics Inc.	LZO	Class II	2013-03-01
K123812	Coherence Rt Therapist Connect Workspace, V2.3, Aria Connectivity Option for Siemens Non-Imaging Systems, Aria Connectiv	Siemens Medical Solutions USA, Inc.	IYE	Class II	2013-03-01
K123802	Easyra Tbil Reagent, Easyra Dbii Reagent, Easyra Ck Reagent	Medica Corp.	CIG	Class II	2013-03-01