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 1278 of 3531

510(k) clearances, page 1278 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K052800	Provisional Inlay/onlay Kit	Dmg USA, Inc.	EBG	Class II	2006-03-07
K052202	Axiom Artis - Modular Angiographic System	Siemens Medical Solutions USA, Inc.	OWB	Class II	2006-03-07
K060379	Ebi Anterior Cervical Plate System	Ebi, LLC	KWQ	Class II	2006-03-06
K060361	Xia Spinal System, Xia 4.5 Spinal System	Howmedica Osteonics Corp	NKB	Class II	2006-03-06
K060224	Modification to Mira-Flex 18 Microcatheter	Cook Incorporated	KRA	Class II	2006-03-06
K060009	Abbott Spine Universal Clamp System	Spinal Concepts, Inc.	JDQ	Class II	2006-03-06
K053567	Athrocare Topaz Arthrowands	ArthroCare Corporation	HRX	Class II	2006-03-06
K053454	Rx Herculink Elite Biliary Stent System	Boston Scientific Corporation	FGE	Class II	2006-03-06
K053319	Allomatrix Custom	Wrightmedicaltechnologyinc	MQV	Class II	2006-03-06
K052953	Nuvance* Facial Rejuvenation System	Ethicon, Inc	MXW	Class II	2006-03-06
K051617	Novabone Putty - Resorbable Bone Void Filler	Novabone Products, LLC	MQV	Class II	2006-03-06
K060292	Kodak Models 2100 and 2200	Kodak-Trophy	EHD	Class II	2006-03-03
K060277	Boehringer Laboratories Suction Pump System	Boehringer Laboratories, LLC	JCX	Class II	2006-03-03
K060086	Feniiiiiix Coloration Kit	Dental Arte, Inc.	EIH	Class II	2006-03-03
K053580	Doctor's Nightguard	Dental Concepts, LLC	MQC	Unclassified	2006-03-03
K053564	Keyed Filler Bottle Adaptor, Models 53450, 53452, 53453, 53454	Penlon, Ltd.	CAD	Class II	2006-03-03
K053531	Dimension Vista Free Thyroxine Flex Reagent Cartridge and Loci 1 Calibrator	Siemens Healthcare Diagnostics Inc.	CEC	Class II	2006-03-03
K053475	Optipoint Corneal Marker, Model Vpt-Opt-450	Refractec, Inc.	HMR	Class I	2006-03-03
K053450	Atlantis Abutment for Zimmer Interface	Atlantis Components, Inc.	NHA	Class II	2006-03-03
K053430	Tono-Pen Avia Tonometer and Ocu-Shiled Tip Cover	Medtronic Xomed, Inc.	HKY	Class II	2006-03-03
K053019	Acuity Steerable Stylet Accessory	Boston Scientific Corporation	DRB	Class II	2006-03-03
K060399	Lc Sprint Nebulizer	Pari Innovative Manufacturers, Inc.	CAF	Class II	2006-03-02
K060209	Aequalis Shoulder Fracture System & Aequalis Shoulder System	TORNIER Inc.	KWS	Class II	2006-03-02
K060069	Palomar Luxir Fractional Handpiece	Palomar Medical Technologies, Inc.	GEX	Class II	2006-03-02
K053012	Fidis Vasculitis, Model Mx007	Biomedical Diagnostics (Bmd) SA	MOB	Class II	2006-03-02
K052881	Vygon Latex Free Bionector	Vygon Corp.	FOZ	Class II	2006-03-02
K052623	Imageless Hip Module for the Stealthstation System	Medtronic Navigation, Inc	HAW	Class II	2006-03-02
K051907	Innocor	Innovision, Inc.	DQK	Class II	2006-03-02
K050975	Nano-Check Ami 3 in 1 Cardiac Disease Test for Cardiac Troponin I, Creatine Kinase Mb and Myoglobin	Nano-Ditech Corporation	MMI	Class II	2006-03-02
K060420	Modification to Whole Pth (1-84) Specific Immunochemilluminometric (Icma) Assay Kit, Model 3Kg002	Scantibodies Laboratory Inc.	CEW	Class II	2006-03-01
K060061	Stryker Injectable Cement	Stryker Corp.	MQV	Class II	2006-03-01
K053640	Integra	Direx Systems Corp.	LNS	Class II	2006-03-01
K053619	Colorbite	Zhermack S.p.A.	ELW	Class II	2006-03-01
K053312	Easymate Blood Glucose Monitoring System	Bioptik Technology, Inc.	NBW	Class II	2006-03-01
K053138	Myset Pregnancy Test	Ani Biotech Oy	LCX	Class II	2006-03-01
K053087	Visualase Cooled Laser Applicator System, Laser Diffusing Fiber, Cooling Catheter System	Biotex, Inc.	GEX	Class II	2006-03-01
K053039	Clinton Electronics Series II Digital Grayscale Monitors, Models Dl2000, Dl3000, Dl2000 of and Dl3000 of	Clinton Electronics Corp.	LLZ	Class II	2006-03-01
K051640	U2 Total Knee System	United Orthopedic Corp.	JWH	Class II	2006-03-01
K060400	Cardioblate Surgical Ablation Generator, Model 68000; Cardioblate Bp2 Surgical Ablation Device, Model 60831; Cardioblat	Medtronic, Inc.	GEI	Class II	2006-02-28
K060279	Cryocare Cs Surgical System	Varian Medical Systems, Inc.	GEH	Class II	2006-02-28
K060034	Nipro Hydrophilic Guidewire for Urological & Laparoscopic Use	Nipro Medical Corporation	OCY	Class II	2006-02-28
K060033	Profile Multi-Platform System	Sciton, Inc.	GEX	Class II	2006-02-28
K053609	Presep and Pediasat Oximetry Catheters and Vigileo Arterial Pressure Cardiac Output/oximetry Monitor	Edwards Lifesciences LLC	DQE	Class II	2006-02-28
K053595	Curay Custom Seed Array	Biolucent, Inc.	KXK	Class II	2006-02-28
K052450	Kd-788 Wrist Measurement Electronic Blood Pressure Monitor	Kodon(Tianjin)Electronic&Electrical Apparatus Co.	DXN	Class II	2006-02-28
K050828	Trojan Supra Lubricated Polyurethane Male Condom	Church & Dwight Co., Inc.	MOL	Class II	2006-02-28
K060348	Modification to: Total Intact Pth Immunochemiluminometric (Icma) Assay Kit	Scantibodies Laboratory Inc.	CEW	Class II	2006-02-27
K060291	Preformance Temporary Cylinder	ZimVie US Corp LLC	NHA	Class II	2006-02-27
K060290	Shoulder Fixation System	Hand Innovations, Inc.	LXT	Class II	2006-02-27
K060256	Unicel Dxc 600I Synchron Access Clinical System	Siemens Healthcare Diagnostics Inc.	CFR	Class II	2006-02-27