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 1366 of 3531

510(k) clearances, page 1366 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K042396	T2 Proximal Humeral Nail	Howmedica Osteonics Corp	HSB	Class II	2004-10-08
K041877	Acu-Strap Motion Sickness Band	Health Ent., Inc.	MVV	Unclassified	2004-10-08
K041874	Abl800 Flex	Radiometer Medical ApS	CHL	Class II	2004-10-08
K041353	Furlong H-Ac Total Hip Replacement System	Jri Manufacturing, Ltd.	MEH	Class II	2004-10-08
K041019	The Fugo Blade for Glaucoma	Medisurg, Ltd.	NCR	Class II	2004-10-08
K040563	Ls Family of CO2 Lasers Including: Ls-15 Laser System (15 Watt) and Ls-25 Laser System (25 Watt)	Sandstone Medical Technologies, LLC	GEX	Class II	2004-10-08
K042763	Modification to Medline Strider Midi 3	MEDLINE INDUSTRIES, LP - Northfield	INI	Class II	2004-10-07
K042692	Clarity Fusion	Shared P.E.T. Imaging, LLC	LLZ	Class II	2004-10-07
K042647	Exam-Pacs	Coactiv, LLC	LLZ	Class II	2004-10-07
K042514	Modification to Blackstone Modular Pedicle Screw System	Blackstone Medical, Inc.	MNI	Class II	2004-10-07
K042508	Sumit Oct Spinal System and Mountaineer Oct Spinal System	DePuy Spine, Inc.	KWP	Class II	2004-10-07
K042499	Orion Anterior Cervical Plating System	Medtronic Sofamor Danek	KWQ	Class II	2004-10-07
K042498	Vertex Reconstruction System	Medtronic Sofamor Danek	KWP	Class II	2004-10-07
K042458	A.m. Surgical Cpf Distal Radial External Cross Pin Fixation System	A.M. Surgical, Inc.	LXT	Class II	2004-10-07
K042453	Modification to Equation Fixation System	Medtronic Sofamor Danek	MNI	Class II	2004-10-07
K042440	Alphatec Femoral Trochanteric Nail (Ftn) System	Alphatec/Nexmed	HSB	Class II	2004-10-07
K042439	Azuryt Model Clt 1401, CO2 Surgical Laser System	Diamond Age Systems, Inc.	GEX	Class II	2004-10-07
K042436	Iiizarov Pulley System	Smith & Nephew, Inc.	KTT	Class II	2004-10-07
K042401	Vari-Able Apb (Adaptable Positioning Base)	American Track Roadsters, Inc.	IOR	Class I	2004-10-07
K042377	Synthes Low Profile Reconstruction Plates	Synthes (USA) Products LLC	HRS	Class II	2004-10-07
K042358	Locon Vls Distal Radius Plate System	Wrightmedicaltechnologyinc	KTT	Class II	2004-10-07
K042356	Synthes 1.0/1.2 Mm Plusdrive Screws	Synthes (USA) Products LLC	HWC	Class II	2004-10-07
K042332	Titanium Telegraph Humeral Nail	Fournitures Hospitalieres Industrie	HSB	Class II	2004-10-07
K042331	Pasco Mic and Mic/id Panels	Pasco Laboratories, Inc.	JWY	Class II	2004-10-07
K042324	Lyphochek Elevated Immunosuppressant Control, Level 4, 5	Bio-Rad	JJY	Class I	2004-10-07
K042201	Novel Vbr Spinal System	Alphatec/Nexmed	MQP	Class II	2004-10-07
K042189	Diazyme Sodium Enzymatic Assay	Diazyme Laboratories, Inc.	MZU	Class II	2004-10-07
K042172	Cleo 90 Infusion Set	Abbott Medical	FPA	Class II	2004-10-07
K042143	Excella-M Spinal System	Innovasis, Inc	KWP	Class II	2004-10-07
K042135	Synthes (USA) Elastic Intramedullary Nail (Ein) System (Line Extension)	Synthes (USA) Products LLC	HSB	Class II	2004-10-07
K042032	Maestro Total Wrist	Zimmer GmbH	JWJ	Class II	2004-10-07
K042001	Panoramic 200A	Optos PLC.	HLI	Class II	2004-10-07
K041774	Iur Reciprocating Morcellator Model # 7210517	Smith & Nephew, Inc.	HIH	Class II	2004-10-07
K041430	Blease Sirius Anesthesia System, Models 3000 and 2000	Blease Medical Equipment, Ltd.	BSZ	Class II	2004-10-07
K041163	Isopure Complete Water System for Hemodialysis, Md 400 and Md 600 Series	Isopure Corp	FIP	Class II	2004-10-07
K041005	Gambro Prismaflex and Gambro Prismaflex M60 & M100 Sets	Gambro Renal Products	KDI	Class II	2004-10-07
K042656	Infinity Gamma/gammaxl and Vista with Vf5	Draeger Medical Systems, Inc.	MHX	Class II	2004-10-06
K042612	Jazzy 600	Pride Mobility Products Corp	ITI	Class II	2004-10-06
K042609	Hospira Mednet Medication Management Suite	Abbott Medical	FRN	Class II	2004-10-06
K042560	Stellar 404 Monitoring System	Larsen & Toubro Limited	MWI	Class II	2004-10-06
K042558	Equi-Flow Valve and Shunt System	Integra Neurosciences Implants S.A.	JXG	Class II	2004-10-06
K042529	Balanceback Vng System	Fall Prevention Technologies, LLC	GWN	Class II	2004-10-06
K042469	Braemar Er800 Series Enhanced Algorithm Event Recorder	Braemar Manufacturing, LLC	MWJ	Class II	2004-10-06
K042423	Verifynow-Aspirin Assay	Accumetrics, Inc.	JOZ	Class II	2004-10-06
K042290	Vacuum Assisted Core Biopsy Device	Hologic, Inc.	KNW	Class II	2004-10-06
K042270	Stat K in Vitro Diagnostic Test System	Stat Chem, Inc.	CEM	Class II	2004-10-06
K042253	Sleepsense Sleep Sensors	S.L.P., Ltd.	MNR	Class II	2004-10-06
K042156	Cardeon Cobra Catheter	Cardeon Corp.	DWF	Class II	2004-10-06
K042060	Easypass US Y-Connector Hemostatic Valve	Millimed A/S	DTL	Class II	2004-10-06
K041994	Multiclear Xl Multiwavelength Targeted Phototherapy System	Curelight, Ltd.	GEX	Class II	2004-10-06