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 1325 of 3531

510(k) clearances, page 1325 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K050784	Nichols Advantage Aldosterone Assay	Nichols Institute Diagnostics	CJM	Class II	2005-06-01
K050763	Vanguard Reprocessed Diagnostic Electrophysiology Catheters	Stryker Sustainability Solutions	NLH	Class II	2005-06-01
K050721	Abx Erytrol	Horiba Abx	JPK	Class II	2005-06-01
K050568	Orlus Mini Screw	Ortholution Co., Ltd.	DZE	Class II	2005-06-01
K043377	Zeno	Tyrell, Inc.	GEX	Class II	2005-06-01
K042644	Aeskulisa Ttg a and Aeskulisa Ttg G	Aesku, Inc.	MVM	Class II	2005-06-01
K042297	Ultra Ivalon and Ultra Drivalon Pva Embolization Particles	Acta Vascular Systems, Inc.	HCG	Class II	2005-06-01
K041897	Mayfield Acciss II Image Guided Surgery System, Model 2002-01	Schaerer Mayfield USA, Inc.	HAW	Class II	2005-06-01
K040871	Facemaster Facial Toning System	Facemaster of Beverly Hills, Inc.	NFO	Class II	2005-06-01
K040290	Diasorin Liaison Cmv Igm/igg	Diasorin Inc.	LFZ	Class II	2005-06-01
K051118	Model Tl-360 Power Scooter	Teh Lin Prosthetic & Orthopaedic, Inc.	INI	Class II	2005-05-31
K051116	Model Tl-560 Power Scooter	Teh Lin Prosthetic & Orthopaedic, Inc.	INI	Class II	2005-05-31
K051086	Smith & Nephew Patello-Femoral Implant	Smith & Nephew, Inc.	KRR	Class II	2005-05-31
K050856	Lcg (Liquide Crystal Glasses) System	Ophthocare, Ltd.	HOY	Class I	2005-05-31
K050638	Lenstec Intraocular Lens (IOL) Injection System for Tetraflex Intraocular Lenses	Lenstec, Inc.	MSS	Class I	2005-05-31
K043442	Stryker RF Coaxial Bipolar Electrodes & Cannulae	Stryker Corp.	GXI	Class II	2005-05-31
K043067	Ena Igg Beadchip Test System, Array Imaging System, Models 800-00025, Ais 400	Bioarray Solutions Limited	LLL	Class II	2005-05-31
K051341	Inion Cps Baby 1.5 Bioabsorbable Fixation System, 40 and 64 Hole Plates, Models Plt-1058 and Plt-1059	Inion Oy	JEY	Class II	2005-05-27
K051252	Micropump Mp-101	Micrel Medical Devices S.A.	FRN	Class II	2005-05-27
K051213	Precision Xtra Plus or Optium Plus, Blood Glucose Test Strips	Abbott Medical	NBW	Class II	2005-05-27
K051173	Spsmedical Sporview Plus Steam Bi Test Pack	Spsmedical Supply Corp.	FRC	Class II	2005-05-27
K051075	Encore Reverse Shoulder Prosthesis	Encore Medical, LP	PHX	Class II	2005-05-27
K051067	Pruitt F3 Outlying and Inlying Carotid Shunt (with and without T-Port)	LeMaitre Vascular Inc.	MJN	Class II	2005-05-27
K050946	Bd Phoenix Automated Microbiology System-Meropenem (Strep) 0.03125-2 Ug/ml	Becton Dickinson & Co	LON	Class II	2005-05-27
K050924	Merete Duothreadtm Bone Screw	Merete GmbH	HWC	Class II	2005-05-27
K050882	Newdeal Ankle Nail	New Deal, S.A.	HSB	Class II	2005-05-27
K050868	Maxlock	TORNIER Inc.	HRS	Class II	2005-05-27
K050861	Peek Cas	Interpore Cross Intl.	MQP	Class II	2005-05-27
K050789	Formagraft Collagen Bone Graft Matrix	R and D Medical, LLC	MQV	Class II	2005-05-27
K050658	Reso-Pac Periodontal Dressing	Hager Worldwide, Inc.	EMA	Class II	2005-05-27
K050557	Amt Nanocath	American Medical Technologies, Inc.	BSO	Class II	2005-05-27
K050454	Omnitech Fulgurating Electrode	Omnitech Systems, Inc.	FAS	Class II	2005-05-27
K050453	Odyssey 2.4G, Denlaser Elite, Model 002-00050	Ivoclar Vivadent, Inc.	GEX	Class II	2005-05-27
K050348	Co Vertebral Body Replacement	Scient'X	MQP	Class II	2005-05-27
K050332	Surgi-Wrap Mast Bioresorbable Sheet	MAST Biosurgery USA, Inc	FTL	Class II	2005-05-27
K050259	Arthrex Bio-Pin	Arthrex GmbH	HTY	Class II	2005-05-27
K050251	Balance Hip System	Zimmer GmbH	KWA	Class III	2005-05-27
K050146	Vascular Solutions D-Stat Clamp Accessory	Vascular Solutions LLC	DXC	Class II	2005-05-27
K050065	Focus Dailies, Focus Dailies Toric and Focus Dailies Progressives	Alcon Laboratories	MVN	Class II	2005-05-27
K050006	Borealis Amplifier (Clearsign), Model 2001232 160 Channel Version, 2001267 80 Channel Version, 2001268 40 Channel Versio	C.R. Bard Inc	DRQ	Class II	2005-05-27
K043342	Polyflux Family Hemodialyzer/filter Labeled for Single and Multiple Use, Models 14L, 17L, 21L, 140H, 170H, 210H,6lr, 8Lr	Gambro Renal Products	FJI	Class II	2005-05-27
K043198	Vanguard Reprocessed Arthroscopic Wands	Stryker Sustainability Solutions	NUJ	Class II	2005-05-27
K042606	Modification To:synthes (USA) Titanium Wire	Synthes (USA) Products LLC	GAQ	Class II	2005-05-27
K042431	Procon2	Incontinent Control Devices, Inc.	KNT	Class II	2005-05-27
K033262	Molecular Adsorbent Recirculating System (Mars)	Gambro Renal Products	FLD	Class II	2005-05-27
K051201	E1 Medical Flat Panel Display System and Mfgd 1218 Medical Flat Panel Display	Barco N.V.	LLZ	Class II	2005-05-26
K051065	Raycell X-Ray Blood Irradiator	Mds Nordion	MOT	Unclassified	2005-05-26
K051064	Ziehm Quantum	Ziehm Imaging GmbH	OWB	Class II	2005-05-26
K051060	Angiodynamics Profiler Pta Balloon Catheter	Boston Scientific Corporation	DQY	Class II	2005-05-26
K050993	Mms Video Option	Medical Measurement Systems B.V.	LLZ	Class II	2005-05-26