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 758 of 3530

510(k) clearances, page 758 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K140878	Straumann Bone Level Tapered Implant	Straumann USA, LLC	DZE	Class II	2014-08-20
K140748	One Step Single/multi-Drug Test Cup, One Step Single/multi-Drug Test Dipcard	Co-Innovation Biotech Co.,Ltd.	DJG	Class II	2014-08-20
K140537	Tenure4g	Den-Mat Holdings, LLC	KLE	Class II	2014-08-20
K140507	Hiossen Prosthetic System	OSSTEM Implant Co., Ltd.	NHA	Class II	2014-08-20
K140347	Ankylos C/x Implant System	Dentsply Intl.	DZE	Class II	2014-08-20
K140270	Nexus Midline CT Catheter	Health Line International Corporation	FOZ	Class II	2014-08-20
DEN140001	Zinc Transporter 8 Antibody (Znt8ab) Elisa Assay Kit	Kronus Market Development Associates, Inc.	PHF	Class II	2014-08-20
K141988	M.u.s.t Pedicle Screw System	Medacta International SA	NKB	Class II	2014-08-19
K141979	Allura Xper Fd Series / Allura Xper or Table Series	Philips Medical Systems Netherland BV	OWB	Class II	2014-08-19
K141772	Immulte 2000 Rubella Quantitative Igg Calibration Verification Material	Siemens Healthcare Diagnostics Inc.	JJX	Class I	2014-08-19
K141136	Leica Fl800	Leica Biosystems Richmond, Inc.	IZI	Class II	2014-08-19
K140723	Nomad Md 75K V Handheld X-Ray System	KaVo Dental Technologies, LLC	IZL	Class II	2014-08-19
K140703	Opa 30 Solution	Ciden Technologies, LLC	MED	Class II	2014-08-19
K133952	Vitek 2 Ast Ys Flucytosine, Vitek 2 Ast Yeast Flucytosine	bioMerieux, Inc.	NGZ	Class II	2014-08-19
K131285	Sonosentry	Isonea, Ltd.	PHZ	Class II	2014-08-19
DEN140016	Studio on the Cloud Data Management Software	Dexcom, Inc.	PHV	Class I	2014-08-19
K142011	Solution Set/extension Set	Baxter Healthcare Corporation	FPA	Class II	2014-08-18
K141769	Optis Integrated System, Dragonfly Optis Imaging Catheter	Lightlab Imaging, Inc.	DQO	Class II	2014-08-18
K141653	Biolox Delta Ceramic Option Heads	Zimmer GmbH	LZO	Class II	2014-08-18
K141352	Endocyn Root Canal Irrigation Solution	Sonoma Pharmaceuticals, Inc.	KJJ	Unclassified	2014-08-18
K141044	M.u.s.t. Extension	Medacta International SA	NKB	Class II	2014-08-18
K140585	Ctc Tcat(r)-Tplan(r) Surgical System	Curexo Technology Corporation	OJP	Class II	2014-08-18
K140330	3M Steri-Drape Fabric Surgical Drapes	3M Healthcare	KKX	Class II	2014-08-18
K133703	Physioglove Et System	Commwell R&D, Ltd.	DXH	Class II	2014-08-18
K132518	Nubrilliance Pulsed Light Hair Removal Device	Wellquest Intl., Inc.	OHT	Class II	2014-08-17
K141951	Dlp Silicone Coronary Artery Ostial Cannulae	Medtronic, Inc.	DWF	Class II	2014-08-15
K141735	Arthrex Ankle Fusion Plating System	Arthrex GmbH	HRS	Class II	2014-08-15
K141129	Exactech Cervical Spacer System	Exactech, Inc.	ODP	Class II	2014-08-15
K141090	Nc Euphora Rapid Exchange Balloon Dilatation Catheter	Medtronic, Inc.	LOX	Class II	2014-08-15
K140966	Vonflex S Bite	Vericom Co., Ltd.	ELW	Class II	2014-08-15
K140933	Alivecor Heart Monitor	AliveCor	DXH	Class II	2014-08-15
K140919	Respiconnect Adapter	Trudell Medical Intl.	CAF	Class II	2014-08-15
K140366	Endlessfiber Reusable Surgical Laser Fiber	Hogue Surgical, LLC	GEX	Class II	2014-08-15
K140308	Mastersurg / Expertsurg	Kaltenbach & Voigt GmbH	EBW	Class I	2014-08-15
K140306	Cormatrix Protect Ecm Envelope	Cormatrix Cardiovascular, Inc.	FTM	Class II	2014-08-15
K133981	Avacen 100	Avacen, Inc.	IRT	Class II	2014-08-15
K133582	Hemosil D-Dimer Hs 500 Control	Instrumentation Laboratory Co.	GGN	Class II	2014-08-15
K132049	Thunderbolt and Lancer Pedicle Screw Systems	Choicespine, LP	NKB	Class II	2014-08-15
K141438	Whitney Medical Solutions Eshield	Whitney Medical Solutions	KKX	Class II	2014-08-14
K141281	Crit-Line Clip (Clic) Blood Chamber	Fresenius Medical Care Renal Therapies Group, LLC	KOC	Class II	2014-08-14
K141153	Ligasure; Curved Small Jaw Sealer/divider, 5Mm Blunt Tip Sealer/divider, Maryland Jaw One Step Stealer/dividers, Curved	Medtronic, Inc.	GEI	Class II	2014-08-14
K141141	Kiva Vcf Treatment System	Benvenue Medical, Inc.	NDN	Class II	2014-08-14
K140737	Straumann Cares Screw Retained Bars/bridge	Straumann USA, LLC	NHA	Class II	2014-08-14
K140508	Zimmer Plates and Screws System(zps)- Non-Sterile Plates and Screws	Zimmer GmbH	HRS	Class II	2014-08-14
K140232	Syngo CT 2014A (Somaris/5 Vb42) for Somatom Emotion & Sensation Family CT	Siemens Medical Solutions USA, Inc.	JAK	Class II	2014-08-14
K133973	Tempus Pro with Enhanced Features	Remote Diagnostic Technologies Ltd.	QYW	Class II	2014-08-14
K132633	Okmeter Direct Blood Glucose Monitoring System	OK Biotech Co., Ltd.	NBW	Class II	2014-08-14
K130720	Synthes Reusable Sterilization Container System	Synthes (USA) Products LLC	KCT	Class II	2014-08-14
K141956	Fibergraft Bg Morsels	Prosidyan, Inc.	MQV	Class II	2014-08-13
K141734	Zimmer Periarticular Locking System	Zimmer GmbH	HRS	Class II	2014-08-13