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 2224 of 3531

510(k) clearances, page 2224 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K935743	Instrument Tray	Cush Medical Products	LRO	Class II	1994-03-03
K935731	Acetabular Shell	Howmedica Corp.	LPH	Class II	1994-03-03
K933233	Ceegraph, Modification	Bio-Logic Systems Corp.	GWQ	Class II	1994-03-03
K932696	Isi(r) Curved, Tapered Dissecting Forceps	Innovative Surgical, Inc.	GCJ	Class II	1994-03-03
K932695	Isi(r) Porpoise Nose Dissecting Forceps	Innovative Surgical, Inc.	GCJ	Class II	1994-03-03
K931919	Catgut Suture Chromic	Surgimetrics International, Ltd.	GAL	Class II	1994-03-03
K931918	Catgut Suture Plain	Surgimetrics International, Ltd.	GAL	Class II	1994-03-03
K931917	Suture Non-Absorbable Synthetic Polypropylene	Surgimetrics International, Ltd.	GAW	Class II	1994-03-03
K931916	Suture Non-Absorbable Synthetic Polyester	Surgimetrics International, Ltd.	GAT	Class II	1994-03-03
K931915	Stainless Steel Suture	Surgimetrics International, Ltd.	GAQ	Class II	1994-03-03
K931913	Suture Non-Absorbable Silk	Surgimetrics International, Ltd.	GAP	Class II	1994-03-03
K930187	Osteonics(r) Arc Depositioned Femoral Components	Osteonics Corp.	JDI	Class II	1994-03-03
K933140	Rqm-1005 Integulaser Ruby Medical Laser System	Laser Photonics, Inc.	GEX	Class II	1994-03-02
K932842	Spacelabs Medical Model 90481 EEG Module	GE Healthcare	GWQ	Class II	1994-03-02
K932465	Li Vasectomy	Femcare Ltd.	KOA	Class I	1994-03-02
K930192	Vci Insuflator Filter W/ Tubing	Vital Concepts, Inc.	HIF	Class II	1994-03-02
K930149	Kotex Discrete Digital Tampons, Reg.,super,super+	Kimberly-Clark Corporation	HEB	Class II	1994-03-02
K925810	Cordis Polypropylene Burr Hole Reservoir	Cordis US Corp.	JXG	Class II	1994-03-02
K915471	Cryobag	Janus Biomedical, Inc.	LPZ	Unclassified	1994-03-02
K940359	Piperacillin/tozobactam, 100/10 Mcg Sensi-Disc	Becton Dickinson Microbiology Systems	JTN	Class II	1994-03-01
K940312	Frame	Lanner Enterprise Co., Ltd.	HQZ	Class I	1994-03-01
K940281	Argedent 51Sf	Argen Precious Metals, Inc.	EJT	Class II	1994-03-01
K940280	Surefire a	Argen Precious Metals, Inc.	EJT	Class II	1994-03-01
K940252	Finesse Porcelain System	Dentsply Intl.	EIH	Class II	1994-03-01
K940095	Fox Eye Aluminum Shield, Ophthalmic	P.J. Products, Inc.	HOY	Class I	1994-03-01
K936117	Central Line Tray	Cush Medical Products	LRO	Class II	1994-03-01
K935948	Convatec Two Piece Absorbent Dressing System	Convatec, A Division of E.R. Squibb & Sons	KGX	Class I	1994-03-01
K935775	Lasersonics Clearpulse Models 50, 70 & 100 CO2 Surgical Laser Systems	Heraeus Surgical, Inc.	GEX	Class II	1994-03-01
K935398	Tracer Series Manual Wheelchairs	Invacare GmbH	IOR	Class I	1994-03-01
K935251	Martinez Orbital Implant	Miguel Martinez M.D.	HPZ	Class II	1994-03-01
K934807	Puncture Closure Device	Advanced Surgical, Inc.	GCJ	Class II	1994-03-01
K934606	Stago Factor II-Deficient Plasma	American Bioproducts Co.	GJT	Class II	1994-03-01
K934605	Stago Factor V-Deficient Plasma	American Bioproducts Co.	GJT	Class II	1994-03-01
K934570	Spectacle Frames	Chaser Optical Corp.	HQZ	Class I	1994-03-01
K934462	Adult Anesthesia Breathing Circuit Kits	Zefon Medical Products	CAI	Class I	1994-03-01
K934031	Sterile Central Line Dressing Tray	Surgipro, Inc.	FRG	Class II	1994-03-01
K933875	Premise Cemented Femoral Stem, Addition Style	Howmedica Corp.	JDI	Class II	1994-03-01
K933713	Venous Reservior/cardiotomy Autotransfusion Filter with Duraflo II Heparin Treatment	Baxter Healthcare Corporation	DTN	Class II	1994-03-01
K933525	Diomed 25 25W Surgical Diode Laser	Dio-Med Corp.	GEX	Class II	1994-03-01
K933449	R and D Batteries, Inc. Part Number 5017	R & D Batteries, Inc.	FCO	Class I	1994-03-01
K933335	River Vial Adapter	River Medical, Inc.	FMF	Class II	1994-03-01
K932730	Excel's Est-30 Ho:yag Laser System	Excel Tech., Ltd.	GEX	Class II	1994-03-01
K932349	Orthopedic Threaded Pin Fixation	Osteomed	JDW	Class II	1994-03-01
K932348	Orthopedic Smooth Pin Fixation	Osteomed	HTY	Class II	1994-03-01
K932122	Biomic Video Plate Reader	Giles Scientific Inc	KZK	Class I	1994-03-01
K931784	Hgm Illuminating Imaging Endocular Probe	Hgm, Inc.	HQF	Class II	1994-03-01
K931524	Fully Threaded Alta Cancellous Bone Screw	Howmedica Corp.	HWC	Class II	1994-03-01
K931264	Infinitech Otoprobe	Infinitech, Inc.	GEX	Class II	1994-03-01
K931058	Tick-Attack(tm) Kit	Mind Mechanics, Inc.	LRR	Not classified	1994-03-01
K930848	Sensing Tip Surgical Trocar	Origin Medsystems, Inc.	GCJ	Class II	1994-03-01