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 1258 of 3531

510(k) clearances, page 1258 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K061453	Hi-Torque Whisper View Guide Wire	Boston Scientific Corporation	DQX	Class II	2006-06-22
K061317	Iled	Trumpf Kreuzer Medizin Systeme GmbH + Co.Kg	FSY	Class II	2006-06-22
K061157	Soflens One Day Plus Disposable (Hilafilcon B) Visibility Tinted Contact Lens	Bausch & Lomb Incorporated	MVN	Class II	2006-06-22
K061120	Synergeyes (Paflufocon D Hem-Iberfilcon a) Hybrid Contact Lenses	Synergeyes, Inc.	HQD	Class II	2006-06-22
K060791	Triage Tox Drug Screen, Model 94400	Biosite Incorporated	DJR	Class II	2006-06-22
K060702	4Cis Vane Spine System	Solco Biomedical Corp.	MNH	Class II	2006-06-22
K060439	Lung Flute	Medical Acoustics	BYI	Class II	2006-06-22
K060404	Ag-Plus, Model 91210	Medel S.p.A.	CAF	Class II	2006-06-22
K061606	Defibrillator Cable Tester, Model Dt2200	Medical Devices/Padpro, Inc.	DRG	Class II	2006-06-21
K061590	Smdie Device Interfacing System	Siemens Medical Solutions Health Services Corporat	MWI	Class II	2006-06-21
K061456	A & D Medical Um-101 Digital Blood Pressure Monitor	A and D Engineering, Inc.	DXN	Class II	2006-06-21
K061205	Medela Vario 8/18/Ci Secretion & Surgical Aspirator	Medela AG	BTA	Class II	2006-06-21
K061032	Depotone	Imprint Pharmaceuticals Limited	FMI	Class II	2006-06-21
K061024	Peregrine Soft Tip Aspirating Laser Probe, Model Pd720.60	Peregrine Surgical, LLC.	HQF	Class II	2006-06-21
K060842	Revjet Turbo	Promedic, Inc.	CAF	Class II	2006-06-21
K060405	Soyala, Soyala Blue	Weinmann Gerate Fur Medizin GmbH + Co. KG	BZD	Class II	2006-06-21
K060300	Confidence High Viscosity Bone Cement	Disc-O-Tech Medical Technologies, Ltd.	NDN	Class II	2006-06-21
K061546	Quart Arterial Filter with Safeline Coating, Model Bsq-Hbf 140	MAQUET CARDIOPULMONARY GmbH	DTM	Class II	2006-06-20
K061347	Vitek 2 Gram Positive Vrsa Screen	bioMerieux, Inc.	LON	Class II	2006-06-20
K061324	Emt Quik-Cover Flexible Endoscope Barrier Sheath, Series 1-7	Rtc Inc.-Memcath Technologies, LLC	FED	Class II	2006-06-20
K061169	Endosseous Dental Implant	Northern Implants, LLC	DZE	Class II	2006-06-20
K061117	Nanolite Skin Care System	Nanolite Technology, Inc.	GEX	Class II	2006-06-20
K061089	Modular Thumb Implant, Models 17600, 17601, 17602, 17603, 17596, 17597, 17598, 17599	Biopro, Inc.	KYI	Class II	2006-06-20
K061281	Insight Head Coil	Insight Neuroimaging Systems, LLC	MOS	Class II	2006-06-19
K061206	Acute Bone Screw	Acute Innovations, LLC	HWC	Class II	2006-06-19
K061203	Ziehm Vision R Digital Mobile Imaging System	Ziehm Imaging GmbH	OWB	Class II	2006-06-19
K061041	US Spine Facet Fixation System	Us Spine	MRW	Unclassified	2006-06-19
K060945	Portex Percutaneous Tracheostomy Kit	Abbott Medical	BTO	Class II	2006-06-19
K060825	Multi-Use Electronic Pregnancy Test	Mizuho USA, Inc.	LCX	Class II	2006-06-19
K060517	Pointer Excel	Lhasa Oms, Inc.	GZJ	Class II	2006-06-19
K060510	Drew Scientific Glycated Hemoglobin Five Level Linearity Kit	Drew Scientific, Ltd.	JJX	Class I	2006-06-19
K060508	Pointer Plus	Lhasa Oms, Inc.	GZJ	Class II	2006-06-19
K060456	Medline Collagen Wound Dressing	MEDLINE INDUSTRIES, LP - Northfield	KGN	Unclassified	2006-06-19
K060431	Anti RNA Polymerase III Elisa Kit, Model 7805	Mbl International Corporation	NYO	Class II	2006-06-19
K060047	Carto Rmt Ep Navigation System V8	Biosense Webster Inc	DRF	Class II	2006-06-19
K053409	3M Liquid Bandage	3M Company	KMF	Class I	2006-06-19
K053400	Acumen Single-Lumen Delivery Sheath	Acumen Medical, Inc.	DYB	Class II	2006-06-19
K042955	Cuticover Skin Barrier Device	D & D Holdings, LLC	KMF	Class I	2006-06-19
K061409	Smartinfuser Painpump, Model P49220 W/catheter Set; P49224n W/o Catheter Set	Precise Medical Products	MEB	Class II	2006-06-16
K060819	Cool.click 2	Medical House Products Limited	KZE	Class II	2006-06-16
K060501	Implantium II	Dentium Co., Ltd.	DZE	Class II	2006-06-16
K060500	Speedy Orthodontic Screw	Dentium Co., Ltd.	DZE	Class II	2006-06-16
K060143	Lncs and Spo2.com Sensors	Masimo Corporation	DQA	Class II	2006-06-16
K052818	Ez Smart-168 Glucose Monitoring System	Tyson Bioresearch, Inc.	NBW	Class II	2006-06-16
K051965	Osteobridge Idsf Intramedullary Diaphyseal Segmental Defect Fixation Rod System	Merete GmbH	HSB	Class II	2006-06-16
K061526	Enseal Ptc Tissue Sealing Device	Surgrx, Inc.	GEI	Class II	2006-06-15
K061464	Vitros Chemistry Products Tibc Kit, Model 886 7541; Calibrator Kit 4, Model 120 4668	Ortho-Clinical Diagnostics, Inc.	JMO	Class I	2006-06-15
K060997	Snap II EEG Monitor	Everest Biomedical Instruments Co.	OLW	Class II	2006-06-15
K060946	Cz-S2000	Parkell, Inc.	KIF	Class II	2006-06-15
K060876	Accu-Chek Insulin Pump Configuration Software (Standard), Model 04625137001; Accu-Chek Insulin Pump Configuration Softwa	Disetronic Medical Systems	LZG	Class II	2006-06-15