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 2392 of 3531

510(k) clearances, page 2392 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K920403	Xenon Arc Endoscope Light Source	Medical Device Inspection Company	GCJ	Class II	1992-02-21
K915851	Quidel Quickvue H. Pylori Controls (Pos. and Neg)	Ortho-Clinical Diagnostics, Inc.	LYR	Class I	1992-02-21
K915553	Usci(r) Hemaflex(tm) Introducer with Coating	C.R. Bard Inc	DYB	Class II	1992-02-21
K915492	Rsp Mega Sample Processor	Tecan U.S.	JQW	Class I	1992-02-21
K915356	Opacitrac	Oculon Corp.	HJO	Class II	1992-02-21
K915337	Capiox Level Alarm	Terumo Medical Corp.	DTW	Class II	1992-02-21
K914579	Silver Foam Wound Dressing	Vitaphore Corp.	FRO	Unclassified	1992-02-21
K914158	Uric Acid Reagent Set	Tech Intl. Co.	KNK	Class I	1992-02-21
K913833	Ventrex Allergen Disc	Ventrex Laboratories, Inc.	DHB	Class II	1992-02-21
K913623	Surgical Electrical Pencil	Aaron Medical, Inc.	GEI	Class II	1992-02-21
K913504	Storz Micro Cutter 25 Gauge Pack	Storz	HQE	Class II	1992-02-21
K913290	Multilase 2100 a	Teknomed, Inc.	GEX	Class II	1992-02-21
K912966	Pediatric Disposable External Defibrilation/ecg	Physio Control, Inc.	LDD	Class II	1992-02-21
K912879	Model Slase 210 Holmium (Thc:yag) Laser System	Sunrise Technologies, Inc.	GEX	Class II	1992-02-21
K912794	Economate/patriot	Foothills Medical Equipment, Inc.	CAW	Class II	1992-02-21
K911646	Ngm Estp Module	Datex Division Instrumentarium Corp.	MHX	Class II	1992-02-21
K915315	Aap Bone Plate	Aap International, Ltd.	HRS	Class II	1992-02-20
K915303	Foil Baby Bunting	Gam Industries, Inc.	KME	Class I	1992-02-20
K915285	Skytron Infinity Series Surgical Lights	Skytron, LLC	FSY	Class II	1992-02-20
K920522	Rionet Hearing Aid Hb-23M	Authorized Hearing Systems, Inc.	ESD	Class I	1992-02-19
K920521	Rionet Hearing Aid Hb-23T	Authorized Hearing Systems, Inc.	ESD	Class I	1992-02-19
K920136	Waters 717 Autosampler	EMD Millipore Corporation	LDM	Class I	1992-02-19
K915443	Urodynamic Catheter	Cook Incorporated	FAP	Class II	1992-02-19
K915310	Kinamed 28Mm Bioceram-Z Total Hip Femoral Ball	Kinamed Inc	LZO	Class II	1992-02-19
K915309	Kinamed 22Mm Bioceram-Z Total Hip Femoral Ball	Kinamed Inc	LZO	Class II	1992-02-19
K915304	Abbott Smart Cap	Abbott Medical	KDJ	Class II	1992-02-19
K915238	Trac-Wright Trac 10 Catheter	Dow Corning Wright	MCW	Class II	1992-02-19
K915168	Proflex 5	Peripheral Systems Group	LIT	Class II	1992-02-19
K914953	Ifa for Chlamydia Trachomatis Igg Antibody	Stellar Bio Systems, Inc.	LKI	Class I	1992-02-19
K914948	Am 300 Agc-O	Electone, Inc.	ESD	Class I	1992-02-19
K914699	Uresil Fixation Device	Uresil, LLC	FGE	Class II	1992-02-19
K914310	Optical Frames & Sunglasses	Societe Nouvelle Idc	HQY	Class I	1992-02-19
K913842	Cordis Right-Angle Catheter Guide	Cordis US Corp.	JXG	Class II	1992-02-19
K913417	Etex Dental Implant System	Etex Corp.	DZE	Class II	1992-02-19
K920487	Mini Vibrator	Alimed, LLC	IRO	Class I	1992-02-18
K920230	Affinity Prg	BD Becton Dickinson Vacutainer Systems Preanalytic	JLS	Class I	1992-02-18
K920184	Angel Wing Safety Blood Collection with Tube Hold.	Mbo Laboratories, Inc.	GIM	Class II	1992-02-18
K920047	Imx Estradiol	Abbott Medical	CHP	Class I	1992-02-18
K915724	Model 6984M Lead Extender Kit	Medtronic, Inc.	DTD	Class II	1992-02-18
K915719	Angeion Endoscopic Valve Seal	Angeion Corp.	ODC	Class II	1992-02-18
K915706	Lipase Reagent Set	Tech Intl. Co.	CET	Class I	1992-02-18
K915579	3D Processing Options for Gyrex	Elscint, Inc.	LNH	Class II	1992-02-18
K915501	Emit D.a.u Benzodiazepine Assay	Syva Co.	JXM	Class II	1992-02-18
K915380	Microprotein-Pr	Sigma Diagnostics, Inc.	CEK	Class II	1992-02-18
K915332	Model 795 Fluorometer/densitometer	Ciba Corning Diagnostics Corp.	JQT	Class I	1992-02-18
K915300	A & Em Medical Electrosurgical Pencil/accessories	Alto Development Corp	GEI	Class II	1992-02-18
K914947	Am 300 Xp	Electone, Inc.	ESD	Class I	1992-02-18
K914874	Manan Pro-Mag Automatic Biopsy Device	Argon Medical Devices, Inc	KNW	Class II	1992-02-18
K914799	Premier K-Amp	Electone, Inc.	ESD	Class I	1992-02-18
K914798	Premier Class D-Asp	Electone, Inc.	ESD	Class I	1992-02-18