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 1837 of 3531

510(k) clearances, page 1837 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K974466	Boston Advance Cleaner	Polymer Technology Corp.	MRC	Class II	1998-02-19
K974435	Michelson Anterior Cervical Plate System	Wrightmedicaltechnologyinc	KWQ	Class II	1998-02-19
K974420	M1730b Tracemaster ECG System, M1766b Local Edit Station, M1798b Remote Edit Station	Hewlett-Packard Co.	DSH	Class II	1998-02-19
K974409	Friedl Gliding Nail System	Plus Orthopedics	KTT	Class II	1998-02-19
K974404	4.0Mm Simpler One Pushin Dental Implant	Vancouver Implant Resources, Inc.	DZE	Class II	1998-02-19
K974403	3.25Mm Simpler One Pushin Dental Implant	Vancouver Implant Resources, Inc.	DZE	Class II	1998-02-19
K974402	3.25 Mm Simpler One Threaded Dental Implant	Vancouver Implant Resources, Inc.	DZE	Class II	1998-02-19
K974389	Koala Intrauterine Pressure Catheter, Koala External Intrauterine Pressure Catheter	Clinical Innovations, LLC	HFN	Class II	1998-02-19
K974385	Mls Electromyographic Preamplifier	Motion Lab Systems, Inc.	IKN	Class II	1998-02-19
K974215	Vet-Co OTC Vacuum Device/vet-Co Constriction Ring Set	Vetco, Inc.	LKY	Class II	1998-02-19
K973962	Bard 9Fr., 30Cc Rediguard and Taperseal Balloons	C.R. Bard Inc	DSP	Class II	1998-02-19
K973465	Latis Graft Cleaning Catheter	Applied Medical Resources Corp	DXE	Class II	1998-02-19
K973318	Mobimed System, (Pegasus and Polaris)	Ortivus Us, Inc.	MSX	Class II	1998-02-19
K980452	Manan Liver Biopsy Kit	Medical Device Technologies, Inc.	KNW	Class II	1998-02-18
K980333	Reliefband	Woodside Biomedical, Inc.	GZJ	Class II	1998-02-18
K980248	Acri R Needle	Gallini U.S., LLC	KNW	Class II	1998-02-18
K980226	Manan Pro-Mag Automatic Biopsy System	Medical Device Technologies, Inc.	KNW	Class II	1998-02-18
K974579	Percscope Model 2600	Clarus Medical Systems, Inc.	HRX	Class II	1998-02-18
K974573	Depuy Motech Moss-Miami Spinal System	Depuy, Inc.	KWP	Class II	1998-02-18
K974537	Synthes Cannulated Angle Blade Plate (Cabp) System	Synthes (USA) Products LLC	KTT	Class II	1998-02-18
K974487	Seac Advanced Dental System - Model 2001,2010 or Model 2020	ASI Medical, Inc.	EIA	Class I	1998-02-18
K974429	Rapet Crp	Stanbio Laboratory	DCN	Class II	1998-02-18
K974406	Orthoplan	Ortho-Graphics, Inc.	HWT	Class I	1998-02-18
K974398	Pulpdent Cavity Varnish	Pulpdent Corporation	LBH	Class II	1998-02-18
K974379	Ultraneb	Bremed Italia, S.r.l.	CAF	Class II	1998-02-18
K974376	Jtech Adjuster Reflex Gun	J-Tech Medical, Inc.	LXM	Unclassified	1998-02-18
K974049	Innovasive Linx Bt 10Mm Ligament Fastener	Innovasive Devices, Inc.	MBI	Class II	1998-02-18
K973760	Affinity Hollow Fiber Oxygenator with Trillium Biopassive Surface	Avecor Cardiovascular, Inc.	DTZ	Class II	1998-02-18
K973381	Bioroc Ez Suture Bone Fastener	Innovasive Devices, Inc.	MAI	Class II	1998-02-18
K973223	Stellar Model Hs-04	Stellar Medical Corp.	IPF	Class II	1998-02-18
K971708	Physiological Monitoring & Biofeedback Training Device	J & J Engineering, Inc.	HCC	Class II	1998-02-18
K980369	T.b.q. Rtu	STERIS Corporation	LRJ	Class I	1998-02-17
K980131	Alex Ta2 Eraser	Light Age, Inc.	GEX	Class II	1998-02-17
K974702	Orgentec Anti-Pr3 (C-Anca) Elisa	American Laboratory Products Company	MOB	Class II	1998-02-17
K974701	Orgentec Anti-Mpo (P-Anca) Elisa	American Laboratory Products Company	MOB	Class II	1998-02-17
K974564	Immage Immunochemistry System Alpha-2-Macroglobulin Reagent	Beckman Instruments, Inc.	DEB	Class II	1998-02-17
K974542	True Vision, True Vision II	Medical Dynamics, Inc.	EIA	Class I	1998-02-17
K974505	Auraflex Ferritin 200 Test Pack 80500, Auraflex Ferritin Calibrator Pack 80501	Alfa Biotech (Uk), Ltd.	DBF	Class II	1998-02-17
K974370	Rapet RF	Stanbio Laboratory	DHR	Class II	1998-02-17
K974355	Interventional Mobile Digital Imaging System (Herein Called Imdis)	GE Dec Medical Systems	OWB	Class II	1998-02-17
K974169	Wielisa Anti-Gbm Test System	Wieslab AB	DBL	Class II	1998-02-17
K974167	Wielisa Pr-3 Anca Test System	Wieslab AB	MOB	Class II	1998-02-17
K974166	Wielisa Mpo Anca Test System	Wieslab AB	MOB	Class II	1998-02-17
K974074	Infusion Dynamics Power Infuser	Infusion Dynamics, Inc.	KZD	Class I	1998-02-17
K973483	Facscomp Software and Calibrite Beads for Use in Flow Cytometer Instrument Set	Becton Dickinson Immunocytometry Systems	GKZ	Class II	1998-02-17
K972554	Reganes Radionuclide Seed Magazine	Avid N.I.T., Inc.	IWJ	Class I	1998-02-17
K972498	Observer * Central Station	Johnson & Johnson MEDICAL GmbH	DSI	Class II	1998-02-17
K971170	Cambridge Biotech Human Lyme Igm Western Blot (90112)	Cambridge Biotech Corp.	LSR	Class II	1998-02-17
K971169	Cambridge Biotech Human Lyme Igg Western Blot (90111)	Cambridge Biotech Corp.	LSR	Class II	1998-02-17
K980220	Iisys Pacs System	Sterling Diagnostic Imaging, Inc.	LMD	Class I	1998-02-13