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 936 of 3530

510(k) clearances, page 936 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K112759	Apclo Pedicle Screw Systems	Atlas Spine, Inc.	NKB	Class II	2011-10-18
K112745	V-14 Control Wire Guidewire	Boston Scientific Corporation	DQX	Class II	2011-10-18
K112586	Ceftaroline 30 Micrograms, Bbl(tm) Sensi-Disc(tm)	Becton, Dickinson & Company (BD)	JTN	Class II	2011-10-18
K112528	Elecsys T4 Calcheck 5	Roche Diagnostics GmbH	JJX	Class I	2011-10-18
K112384	Abdominal Tourniquet System	Compression Works Inc.	DXC	Class II	2011-10-18
K112323	Cardia-Cath	Millar LLC.	DXO	Class II	2011-10-18
K111979	Radioactive Seed Localization Needle	Biocompatibles, Ltd.	KXK	Class II	2011-10-18
K111909	Vitek 2 Streptococcus Inducible Clindamycin Resistance	bioMerieux, Inc.	LON	Class II	2011-10-18
K111904	Ark Methotrexate Assay, Ark Methotrexate Calibrator, Ark Methotrexate Control, Ark Methotrexate Control (Calibration Ran	Ark Diagnostics Inc	LAO	Unclassified	2011-10-18
K111883	Smartloc Spinal Fixation System	A-Spine Asia, Co., Ltd.	MNI	Class II	2011-10-18
K110716	Everyway Low Back Pain Relief System	Everyway Medical Instruments Co., Ltd.	NUH	Class II	2011-10-18
K110021	Dash Hip	Brainlab, Inc.	OLO	Class II	2011-10-18
K112874	Ez Vein Inflatable Tourniquet	Dominion Medical Devices, LLC	KCY	Class I	2011-10-17
K112710	Zenotec Zr Bridge, Zenostar Zr Translucent, Zenotec Color Zr, Zenostar Color Zr	Wieland Dental + Technik GmbH & Co. KG	EIH	Class II	2011-10-17
K112439	Synapse Workstation Software Version 3.3.0	FUJIFILM Healthcare Americas Corporation	LLZ	Class II	2011-10-17
K112358	Unimax Trocar System	Unimax Medical Systems Inc.	GCJ	Class II	2011-10-17
K112156	Codman Certas Programmable Valve System, Codman Certas Therapy Management System	Medos International SARL	JXG	Class II	2011-10-17
K112032	8Fr Turbo - Tandem System	Spectranetics Corp.	DQY	Class II	2011-10-17
K112014	Zyston Straight Spacer System	Highridge Medical, LLC	MAX	Class II	2011-10-17
K111990	Coronis 5Mp	Barco N.V.	LLZ	Class II	2011-10-17
K111408	Microgard II	Carefusion Germany 234 GmbH	CAH	Class II	2011-10-17
K111354	Gs Medical Anyplus Peek Lumbar Cages (Alif and Dlif)	GS Medical Co., Ltd.	MAX	Class II	2011-10-17
K111311	Segmentation Assistant for Prostate-Auto Contouring	Omisa Inc. (Segasist Technologies)	MUJ	Class II	2011-10-17
K110951	27+ Ultravit Probe, 27+ Flex-Tip Laser Probe, 27+ Endoilluminator Probe, 27+ Valved Entry System, 27+ Infusion Cannula	Alcon Laboratories	HQB	Class II	2011-10-17
K103598	Prophecy Pre-Operative Navigation Alignment Guides	Wrightmedicaltechnologyinc	MBH	Class II	2011-10-17
K112773	Novabne Putty Bioactive Synthetic Bone Graft	Novabone Products, LLC	MQV	Class II	2011-10-14
K112771	Bmr1900 Ph.i.s.i.o Venous Reservoir Bag	Corcym Inc.	DTN	Class II	2011-10-14
K112694	Edwards Lifesciences Endoclamp Aortic Catheter	Edwards Lifesciences LLC	DXC	Class II	2011-10-14
K112370	Welldoc Diabetes Manager System and Diabetes Manager Rx System	Welldoc	MRZ	Class II	2011-10-14
K112086	Medrad Mark 7 Arterion (Pedestal System / Table Mount System), Medrad Mark 7 Arterion Syringe	Medrad, Inc.	DXT	Class II	2011-10-14
K111980	Clearfil Tri-S Bond Plus	Kuraray America, Inc.	KLE	Class II	2011-10-14
K111975	Clearfil Tri-S Bond Plus Single Dose Standard / Value / Introductory Pack	Kuraray Medical, Inc.	KLE	Class II	2011-10-14
K111958	Tetric Evoceram Bulk Fill	Ivoclar Vivadent, Inc.	EBF	Class II	2011-10-14
K111910	Gladiator Hip Stem	Wrightmedicaltechnologyinc	KWA	Class III	2011-10-14
K111737	Disposable Electrode	Sanibel Supply	GXY	Class II	2011-10-14
K111610	Trilogy Series Ventilator with Oximetry	Respironics, Inc.	CBK	Class II	2011-10-14
K111436	Porcine Surgical Mesh, Porcine Dermal Matrix	Brennen Medical, Inc.	FTM	Class II	2011-10-14
K111120	Csm Submerged-R Implant System	CSM Implant	DZE	Class II	2011-10-14
K110586	Advia Centaur Vitamin D Total Assay	Siemens Healthcare Diagnostics Inc.	MRG	Class II	2011-10-14
K110250	Mpxx Powder Free Natural Rubber Examination Gloves	Total Gloves Sdn Bhd	LYY	Class I	2011-10-14
K110135	Polarcup Dual Mobility System	Smith & Nephew, Inc.	LPH	Class II	2011-10-14
K103752	Vitek 2 Systems (Pc) 5.02 Software	bioMerieux, Inc.	LON	Class II	2011-10-14
K103627	Architect Icarbamazepine Icarbamazepine Reagents; Architect Icarbamazepine Calibrators	Abbott Medical	KLT	Class II	2011-10-14
K102346	Randox Digoxin Assay	Randox Laboratories, Limited	KXT	Class II	2011-10-14
K111978	Sulcus Blue	Produits Dentaires Pierre Rolland	MVL	Unclassified	2011-10-13
K111597	Disposable Stimulating Electrode	NuVasive Inc	ETN	Class II	2011-10-13
K111492	Zimmer Patient Specific Instruments Planner Model 2.5, Zimmer Patient Specific Instruments	Materialise N.V.	JWH	Class II	2011-10-13
K110407	Invisiport	Stealth Therapeutics, Incorporated	LJT	Class II	2011-10-13
K110003	Mtf New Bone Void Filler	Musculoskeletal Transplant Foundation d/b/a/ MTF Biologics	MQV	Class II	2011-10-13
K103757	Immunofixation Electrophoresis Test Using Interlab G26 Instrument	Grifols	CFF	Class II	2011-10-13