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 2504 of 3531

510(k) clearances, page 2504 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K902896	49-610 Niko-Nose Fixation Tape	Nikomed U.S.A., Inc.	CBH	Class I	1990-10-23
K902799	Gyroscan S15/acs	Philips North America LLC	LNH	Class II	1990-10-23
K902301	Sunshades, Acrylic Lenses #Sg-01	Tel-Time Products	HQY	Class I	1990-10-23
K902093	Resu-Gard Catheter Suction	Amg Medical Equipments, Inc.	BSY	Class I	1990-10-23
K901401	Davol Autotransfusion Blood Processing System	Davol, Inc.	CAC	Class II	1990-10-23
K900434	Mm-22 Microtron, Mm50 Microtron	Scanditronix, Inc.	IYE	Class II	1990-10-23
K897173	System 7100 Non-Invasive Blood Pressure Monitor	Advanced Medical Instruments, Inc.	DXN	Class II	1990-10-23
K904414	Datascope Percor Stat Dl 9.5 Fr40cc Steril Eto Gas	Datascope Corp.	DSP	Class II	1990-10-22
K904292	Accu-Chek(r) III Blood Glucose System	Boehringer Mannheim Corp.	CGA	Class II	1990-10-22
K904219	Synchron Cx 7 Clinical Analyzer	Beckman	JJE	Class I	1990-10-22
K904205	Amk Modular Tibial Wedge System	Depuy, Inc.	JWH	Class II	1990-10-22
K904073	Coagulation Reference Plasma, Abnormal	Medi-Tech, Inc.	GGC	Class II	1990-10-22
K903937	Target(tm) Hog One Step	V-Tech, Inc.	JHI	Class II	1990-10-22
K903841	Organon Teknida Chromostrae (Tm) Heparin Anti-Xa	bioMerieux, Inc.	KFF	Class II	1990-10-22
K903703	Patient Examination Gloves	P.T. Tulip Indah Agung	LYY	Class I	1990-10-22
K903609	Serotonin Enzyme Immunoassay	IMMUNOTECH s.r.o.	CDA	Class I	1990-10-22
K903590	Kejump Digital Clinical Thermometer	K-Jump Health Co., Ltd.	FLL	Class II	1990-10-22
K903530	Percutaneous Introducers	Davol, Inc.	DYB	Class II	1990-10-22
K903502	Lifecoil Catheter	Lifemed of California	FJS	Class II	1990-10-22
K903420	Soehendra Stent Retriever	Wilson-Cook Medical Inc.	FGE	Class II	1990-10-22
K903362	Osteolock(tm) Acetabular Cup	Howmedica Corp.	JDI	Class II	1990-10-22
K903348	Ultrasonic Pulsed Doppler Imaging System	Advanced Technology Laboratories, Inc.	HGL	Class II	1990-10-22
K903331	Rozinn 151	Rozinn Electronics, Inc.	DSH	Class II	1990-10-22
K902756	Tropi-Cool	Seabrook Medical Systems, Inc.	DWJ	Class II	1990-10-22
K902730	Spo2 Option	Protocol Systems, Inc.	DQA	Class II	1990-10-22
K902599	Revised High Voltage Stimulator Intelect 150	Chattanooga Group, Inc.	IPF	Class II	1990-10-22
K902190	Fetal Pulse Detector Model Dop-1	Advanced Medical Systems, Inc.	HEK	Class II	1990-10-22
K901592	Model Md-5 Doppler	D. E. Hokanson, Inc.	DXK	Class II	1990-10-22
K901581	Gsb Elbow	Allo Pro Corp.	JDC	Class II	1990-10-22
K901260	Coradent	Ivoclar North America, Inc.	EBF	Class II	1990-10-22
K900647	Southern Cross Hi-V4 Pulsed High Voltage Galvanic	Nor-Am Patient Care Products, Inc.	IPF	Class II	1990-10-22
K900616	Shepperd Cutting Forceps	Downs Surgical, Ltd.	HRX	Class II	1990-10-22
K900615	Shepperd Nerve Root Retractor W/suction & Fibre	Downs Surgical, Ltd.	HRX	Class II	1990-10-22
K900614	Shepperd Short Muscle Retractor (Gs-501-45-V)	Downs Surgical, Ltd.	HRX	Class II	1990-10-22
K900613	Shepperd Shelter Tube Complete & Drill	Downs Surgical, Ltd.	HRX	Class II	1990-10-22
K900612	Shepperd Trephine Set (Gs-501-30-V)	Downs Surgical, Ltd.	HRX	Class II	1990-10-22
K900611	Shepperd Dilatation Tube Set (Gs-501-20-H)	Downs Surgical, Ltd.	HRX	Class II	1990-10-22
K900610	Shepperd Cannula Stillette & Obdurator Set	Downs Surgical, Ltd.	HRX	Class II	1990-10-22
K900609	Shepperd Straight and Curved Needles	Downs Surgical, Ltd.	HRX	Class II	1990-10-22
K900608	Shepperd Lumbar Discectomy System	Downs Surgical, Ltd.	HRX	Class II	1990-10-22
K904642	Vinyl Examination Gloves(mfg:kao Ying Industrial)	Predex Co., Ltd.	LYZ	Class I	1990-10-19
K904641	Latex Examination Gloves(mfg: Modlook Industries)	Predex Co., Ltd.	LYY	Class I	1990-10-19
K904366	Crystal Focus Emerald-Cw Laser Photocoagulator	Douglas James Donaldson Compliance Services	HQF	Class II	1990-10-19
K904340	Fastlok (Staple and Buckle) Fixation System	Neoligaments, Ltd.	JDR	Class II	1990-10-19
K904162	Carbon Dioxide Flowthrough Laser Mixtures	Norco, Inc.	GEX	Class II	1990-10-19
K904018	Datascope Percor Stat Dl 9.5 Fr 40Cc Intra-Aor Bal	Datascope Corp.	DSP	Class II	1990-10-19
K903994	Ureteropyelogram Cath for Retrograde Dye Injection	Applied Urology, Inc.	FGF	Class II	1990-10-19
K903893	Datascope Percor Stat 9.5 Fr 40Cc Intra-Aortic Bal	Datascope Corp.	DSP	Class II	1990-10-19
K903892	Datascope Percor Stat 8.5 Fr 40Cc Intra-Aortic Bal	Datascope Corp.	DSP	Class II	1990-10-19
K903867	Datascope Percor Stat Dl 10.5 Fr 40Cc	Datascope Corp.	DSP	Class II	1990-10-19