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 935 of 3530

510(k) clearances, page 935 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K110569	Audicor Cpam (Cardiopulmonary Ambulatory Monitor)	Inovise Medical, Inc.	MLO	Class II	2011-10-24
K103513	Lateral Superior Clavicle Plate, Left and Right; Midshaft Superior Clavicle Plate, Left and Right; Anterior Clavicle Pla	Advanced Orthopaedic Solutions, Inc.	HRS	Class II	2011-10-24
K102387	Mediscope Compressiopn Staple and Accessories	Mediscope Manufacturing, Inc.	JDR	Class II	2011-10-24
K102329	Nanoknife System	Boston Scientific Corporation	OAB	Class II	2011-10-24
K112746	Dioslimon Implant System	Dio Corporation	DZE	Class II	2011-10-21
K112473	Cd Horizon Spinal System	Medtronic Sofamor Danek	NKB	Class II	2011-10-21
K112415	Lifecare Arm & Leg Pain Relief System	Everyway Medical Instruments Co., Ltd.	NUH	Class II	2011-10-21
K112292	Reprocessed 2515 Nav Variable Electrophysiology Catheter	Stryker Sustainability Solutions	NLH	Class II	2011-10-21
K112166	Ultralase Flexible CO2 Laser Waveguide	W and R Investments dba Laser Engineering	GEX	Class II	2011-10-21
K111854	Ao Usb Receiver, Wi-Box, Wi-Box Psu Kit, Wi-Box Xpress Cable, Pw Usb Receiver	St. Jude Medical Systems AB	DRG	Class II	2011-10-21
K111639	Fresenius 2008T Hemodialysis Machine	Fresenius Medical Care	KDI	Class II	2011-10-21
K111030	E.g. Scan (Tm) Esophagoscope System	IntroMedic Co., Ltd.	EOX	Class II	2011-10-21
K110992	Enspire Debrider System	Spine View, Inc.	HRX	Class II	2011-10-21
K103791	Physioglove Es with ECG Analysis	Commwell, Ltd.	DPS	Class II	2011-10-21
K103684	Vreselect Culture Medium	Bio-Rad	JSO	Class II	2011-10-21
K112974	Picture Archiving and Communications System	Curve Dental, Inc.	LLZ	Class II	2011-10-20
K112788	Eastlyte Na/k/ca/ph	Medica Corp.	CEM	Class II	2011-10-20
K112744	Sapiens Tip Confirmation System	C.R. Bard Inc	LJS	Class II	2011-10-20
K112737	Tiger Headless Cannulated Screws	Trilliant Surgical LLC	HWC	Class II	2011-10-20
K112661	Vizion Dr	Viztek, LLC	MQB	Class II	2011-10-20
K112626	Lipsonix(r) System Model 2	Medicis Technologies Corporation	OHV	Class II	2011-10-20
K112512	Vanishpoint Blood Collection Set	Retractable Technologies, Inc.	FPA	Class II	2011-10-20
K112468	The Oncontrol Bone Access System by Vidacare	Regulatory Specialists, Inc.	KNW	Class II	2011-10-20
K112374	X-Tra Base	Voco GmbH	EBF	Class II	2011-10-20
K112283	Dura Blue Sterilization Wrap	Cardinal Health200, LLC	FRG	Class II	2011-10-20
K112269	Ostar Usb Blood Pressure Monitor with Spectrum / P200 for Upper Arm, and M100 for Wrist Type	Ostar Meditech Corp.	DXN	Class II	2011-10-20
K112267	Neurolac(r) Nerve Guide	Polyganics B.V.	JXI	Class II	2011-10-20
K112211	Dura Blue Sterilization Wrap	Cardinal Health200, LLC	FRG	Class II	2011-10-20
K111772	Powder Free Nitrile Patient Examination Glove, Blue Colored and White (Non-Colored). Non-Sterile	Kossan Latex Industries (M) Sdn Bhd	LZA	Class I	2011-10-20
K111587	Alerkan Spirometry Filter	Alerkan Ltd	BZG	Class II	2011-10-20
K111542	Deltex Medical Cardioq Edm	Deltex Medical Limited	DPW	Class II	2011-10-20
K111414	Quanta Flash (Tm) Dgp Screen	Inova Diagnostics, Inc.	MST	Class II	2011-10-20
K111402	Kc200, Surgical Mask, Kc200, Procedure Mask, Kc300, Surgicalmask, Fluidshield, Kc300, Procedure Mask, Fluidshield Model	Kimberly-Clark Corporation	FXX	Class II	2011-10-20
K111155	Xtrafix External Fixation System	Extraortho, Inc.	KTT	Class II	2011-10-20
K110979	Dermagrip Ultra Powder Free Blue Nitrile Patient Examination Gloves Non-Sterile,tested for Use W/ Chemotherapy Drugs	Advanced Medical Products Sdn Bhd	LZA	Class I	2011-10-20
K110919	Carestream Pacs	Eastman Kodak Company	LLZ	Class II	2011-10-20
K110912	Smart Touch Uvtherapy Multiple Machine	The Daavlin Distributing Co.	FTC	Class II	2011-10-20
K110432	Visucon-F Frozen Coag Screen N, Visucon-F Frozen Coag Screen Abn	Affinity Biologicals Inc.	GGN	Class II	2011-10-20
K110315	Nexgen Peripheral Mechanical Retrieval Device	Nexgen Medical Systems, Inc.	QEZ	Class II	2011-10-20
K103348	Digiview 250	Kub Technologies, Inc.	MQB	Class II	2011-10-20
K103320	Synthes Xrl	Synthes Spine Co.Lp	MQP	Class II	2011-10-20
K102416	Bd Geneohm Vanr Assay	BD Diagnostics Science	NIJ	Class II	2011-10-20
K102278	Quadra Bloc TENS Plus	Gradient Technologies, LLC	GZJ	Class II	2011-10-20
K101286	Sedara Gas Mixer, Sedara Scavenger Model: 03, 04	Linde Healthcare AB	BZR	Class II	2011-10-20
K112098	Tbd	LENSAR, Inc	OOE	Class II	2011-10-19
K111766	Supera Veritas Interwoven Self-Expanding Nitinol Stent Transheptic Biliary Systems	Idev Technologies, Inc.	FGE	Class II	2011-10-19
K110804	Amt G-J Tube	Applied Medical Technology Inc	KNT	Class II	2011-10-19
K110345	Scanview System	Applied Spectral Imaging, Ltd.	NTH	Class II	2011-10-19
K112929	Thermoflash(tm) Infrared Thermometer	Visiomed Group SA	FLL	Class II	2011-10-18
K112893	Clearlink Luer Activated Valve, Clearlink System Non-Dehp Catheter Extension Sets	Baxter Healthcare Corporation	FPA	Class II	2011-10-18