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 2026-11-02, 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 1052 of 3531

510(k) clearances, page 1052 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K092547	Dentimax Digital X-Ray Imaging System Sensor Size 1, 2, Dentimax Usb Control Box	Dentimax, Inc	MUH	Class II	2009-10-30
K092536	Spinal Fixation System	Lanx, LLC	NKB	Class II	2009-10-30
K092403	Ti Prepable Abutment, Model 1618, 1619, 1620	ZimVie US Corp LLC	NHA	Class II	2009-10-30
K092342	Smartpill Gi Monitoring System, Version 2.0	The Smartpill Corporation	NYV	Class II	2009-10-30
K092318	Baxject II Hi-Flow Needleless Transfer Device	Baxter Healthcare Corporation	LHI	Class II	2009-10-30
K092309	Single Use Electrosurgical Knife Series, Model Kd-610L, Kd-611L, Kd-620Lr, Kd-630L, Kf-640L	Olympus Medical Systems Corp.	KNS	Class II	2009-10-30
K092251	Biodentine	Septodont	KIF	Class II	2009-10-30
K092205	Palindrome P Hemodialysis Catheter	Covidien Lp, Formerly Registered AS Kendall	MSD	Class II	2009-10-30
K091913	Hi Tech Implant, Ht Physio Implant	By Dental SRL	EKX	Class I	2009-10-30
K091736	Sharpsmart Disposable Sharps Container, Model S2	Daniels Corporation Pty, Inc.	MMK	Class II	2009-10-30
K091512	Build-It Light Cure	Pentron Clinical Technologies	EBF	Class II	2009-10-30
K091441	Synergetics Adjustable Gas Pressurized Infusion (Agpi) Tube Set	Synergetics Inc	FRN	Class II	2009-10-30
K091115	Eco2 Laser System	Lutronic Corporation	GEX	Class II	2009-10-30
K090887	Orio-C Cervical, Orio-Tl Tlif, Orio-Pl Plif, Orio-Al Alif Intervedrtebral Body Fusion Cages	Spinecraft LLC	ODP	Class II	2009-10-30
K090539	BIPAP Autosv Advanced	Respironics Inc., Sleep & Home Respiratory Group	MNS	Class II	2009-10-30
K083133	Silveri: Coflex Afd, Coflex Afd First Aid, Afd Pad Foam Dressing, Powerflex Afd Foam Dressings	Andover Healthcare Inc.	FRO	Unclassified	2009-10-30
K093251	Omniguide Beampath Fels 25A CO2 Laser System	Omni-Guide Holdings, Inc.	GEX	Class II	2009-10-29
K093023	PTFE Peelable Introducer	Great Batch Medical	DYB	Class II	2009-10-29
K092361	Reef Hp 0.035 Otw Pta Balloon Dilatation Catheter	Invatec S.p.A.	LIT	Class II	2009-10-29
K092355	Monolisa Anti-Hav Eia	Bio-Rad Laboratories Inc.	LOL	Class II	2009-10-29
K092353	Monolisa Anti-Hav Igm Eia	Bio-Rad Laboratories Inc.	LOL	Class II	2009-10-29
K091916	Innovance D-Dimer, Model Opbp09	Siemens Healthcare Diagnostics Inc.	DAP	Class II	2009-10-29
K091761	Teleflex Isis Hvt Tracheal Tube, Cuffed, with Subglottic Secretion Suction Port	Teleflexmedical, Inc.	BTR	Class II	2009-10-29
K091290	Ethicon Endo-Surgery Rotating Hook Knife, Model In2508	Ethicon Endo-Surgery Inc	GEI	Class II	2009-10-29
K090689	Quadrox-I Small Adult with and without Intergrated Arterial Filter with Softline Coating, Models Hmo 50000, Hmo 51000	MAQUET CARDIOPULMONARY GmbH	DTZ	Class II	2009-10-29
K090639	Exelo2, Model 4010	Quantel Derma GmbH	ONG	Class II	2009-10-29
K083080	Igx Plex Rheumatoid Arthritis (Ra) Assay and Sqidworks Diagnostics Platform	Sqi Diagnostics Systems	DHR	Class II	2009-10-29
K093002	Azur Peripheral Hydrocoil Endovascular Embolization System-Detachable 35, Models 45-450405, 45-450410, 45-450610	Terumo Cardiovascular Systems Corporation	KRD	Class II	2009-10-28
K092926	Acell Matristem Wound Sheet	ACell, Inc	KGN	Unclassified	2009-10-28
K092292	Checkpoint	Ndi Medical, LLC	ETN	Class II	2009-10-28
K092245	Aneroid Sphygmomanometer with Stethoscope, Model Ld-100	HONSUN (NANTONG) Co., Ltd.	DXQ	Class II	2009-10-28
K092011	Norm Spinal System	Norm Tibbi Urunler Ithalat Ihracat Sanayi ve Ticar	MNH	Class II	2009-10-28
K091984	Immulite 2000 3Gallergy Specific Ige Assay Kit, Model L2kun6	Siemens Healthcare Diagnostics Inc.	DHB	Class II	2009-10-28
K091726	Nexus Xpulse 805 Ir Lamp System, Nexus Xpulse 980 Ir Lamp System, Model 805, 980	USA Laser Biotech, Inc.	ILY	Class II	2009-10-28
K091566	Zimmer Natural Nail System Cephalomedullary Nails	Zimmer GmbH	HSB	Class II	2009-10-28
K091433	R&d Systems Tetic-I Plus Hemotology Control	R & D Systems, Inc.	JPK	Class II	2009-10-28
K091284	Visucal-F Frozen Calibrator Plasma and Visucon-F Frozen Normal and Abnormal Control Plasma	Affinity Biologicals Inc.	GGN	Class II	2009-10-28
K082584	Given Electrosurgical Needle	Tripps Court Enterprises, Inc.	GEI	Class II	2009-10-28
K092986	Acacia Piston Syringe	Acacia, Inc.	FMF	Class II	2009-10-27
K092873	Reverse Shoulder Prosthesis	Encore Medical, LP	PHX	Class II	2009-10-27
K092381	Ibalance Akrfx Medial Opening Wedge Tibial System, Ifx Medial Peek Implant and Anchor, Akrfx Instrumentation	Ibalance Medical, Inc.	HRS	Class II	2009-10-27
K092303	Merit Laureate Hydrophilic Guide Wire	Merit Medical Systems, Inc.	DQX	Class II	2009-10-27
K092281	Clearfil Majesty Posterior Plt	Kuraray Medical, Inc.	EBF	Class II	2009-10-27
K092150	Cobalt Mv with Gentamicin (Aka Cobalt G-Mv) Bone Cement	Zimmer GmbH	LOD	Class II	2009-10-27
K091915	Fluid Isolation Device	Lenstec, Inc.	HQC	Class II	2009-10-27
K091446	Modification to Lux1540 Handpiece and Lux 1440 Handpiece	Palomar Medical Products, Inc.	ONG	Class II	2009-10-27
K091196	Grs Glenoid Resurfacing System	Arthrosurface, Inc.	KWS	Class II	2009-10-27
K091174	Verify V-Pro Chemical Indicator, Version 1A: Verify V-Pro Chemical Indicator; Version 2A: Adhesive Label	STERIS Corporation	JOJ	Class II	2009-10-27
K091064	Navilas Laser System	Od-Os GmbH	HQF	Class II	2009-10-27
K090139	Ankle Arthrodesis Plate System	TORNIER Inc.	HRS	Class II	2009-10-27