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 2026-10-21, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,018 of the 176,415 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	2,618

176,415 records, page 3020 of 3529

510(k) clearances, page 3020 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K844719	360 Infuser	BD Becton Dickinson Vacutainer Systems Preanalytic	FRN	Class II	1985-01-28
K844718	Model 1001	A0kfusion Systems, Inc.	FRN	Class II	1985-01-28
K844627	Stratofuse Syringe Piggyback Pump	Strato Medical Corp.	FRN	Class II	1985-01-28
K843899	Grc-Wt, Grc-W	Olympus Corp.	HKI	Class II	1985-01-28
K843781	Kinair, Low Air Loss Bed	KCI USA, Inc.	FNL	Class II	1985-01-28
K844937	Ivac 52-99-0 Unvented & 52-99-1 Vented Vol. Infusi	Y	FPA	Class II	1985-01-25
K844880	Huntleigh Air-O-Pad Aop1 Alternating Press-Mattres	Huntleigh Technology, Inc.	FNM	Class II	1985-01-25
K844879	Huntleigh Alphacare, Hm95 Alternating Press-Pump	Huntleigh Technology, Inc.	FNM	Class II	1985-01-25
K844768	Abbott Lifecare 500 Infuser	Abbott Medical	FRN	Class II	1985-01-25
K844407	Directigen Neissena Menningitidis Group B Test	BD Becton Dickinson Vacutainer Systems Preanalytic	GTJ	Class II	1985-01-25
K844200	K.m. Products Aspirator	Km Products	BTA	Class II	1985-01-25
K844091	Abbott Lifecare 900 Volumetric Pump	Abbott Medical	FRN	Class II	1985-01-25
K843609	Elex Electronic Digital Thermometer	Ewing Intl., Ltd.	FLL	Class II	1985-01-25
K843544	The Bibicure Sys Breast Toner	Les Entreprises Bibi, Inc.	HGY	Class I	1985-01-25
K841048	Transducer 4.Omhz La4011	Philips North America LLC			1985-01-25
K850111	Aires Tuohy Needles 17Ga. X 4 1/2	Aries Medical, Inc.	BSP	Class II	1985-01-24
K850106	Airco Nitrous Oxide Regulator	Airco, Inc.	CAN	Class I	1985-01-24
K850066	Omnimed Nasal Oxygen Cannula	Omni Intl., Inc.	CAT	Class I	1985-01-24
K844811	Pace Aid Model 53	Cardiac Resucitator Corp.	DRO	Class II	1985-01-24
K844584	Gore-Tex Tunneler	W. L. Gore & Associates, Inc.	DWS	Class I	1985-01-24
K844352	Sundt-Kees Reinforcing Aneurysm Clip	Kees Surgical Specialty Co., Inc.	HCH	Class II	1985-01-24
K844279	Interceptor, 662-01	Intermedics, Inc.	GZJ	Class II	1985-01-24
K844228	Pds Polydioxanone Mesh	Ethicon, Inc	FTM	Class II	1985-01-24
K841254	Cardiovit Cv-3	Schiller, AG	DPS	Class II	1985-01-24
K850016	Towel Pack, Surgical	East Texas Lighthouse for the Blind			1985-01-23
K850014	Hit Kit (Hydrodynamic Impression Technique	Medi-Dent American, Inc.	EBH	Class I	1985-01-23
K844991	Emit Phenytoin Assay	Syva Co.	DIP	Class II	1985-01-23
K844990	Syva Advance Emit Phenytoin Assay	Syva Co.	LES	Class II	1985-01-23
K844985	In the Ear Model X-Ite 84	Bernafon LLC	ESD	Class I	1985-01-23
K844838	Skin Stat II Skin Stapling Medical Device	Edward Weck, Inc.	GDT	Class I	1985-01-23
K844837	Visistat Skin Stapling Device	Edward Weck, Inc.	GDT	Class I	1985-01-23
K844836	Hemoclip X-20 Automatic Hemoclip Ligating Applier	Edward Weck, Inc.	GWD	Class II	1985-01-23
K844744	Cardio Iv/gxt Stress Testing System	Intl. Medical, Inc.	DPS	Class II	1985-01-23
K844728	Advanced Hearing Instruments - Hearing Aids	Advanced Hearing Instruments	ESD	Class I	1985-01-23
K844477	Storz Corneo-Scan II Cs2000	Storz Instrument Co.	IYO	Class II	1985-01-23
K844472	Civco Scan Drape	CIVCO Medical Instruments Co., Inc.	IYO	Class II	1985-01-23
K844449	High Resolution 5 Mhz Linear Array	Siemens Medical Solutions USA, Inc.	IYO	Class II	1985-01-23
K844415	Porocoat New Jersey Shoulder Replacement Sys	Depuy, Inc.	MBF	Class II	1985-01-23
K844347	Fisher Diag. Pregnaclone Tube Pregnancy Test Kit	Fisher Diagnostics	JHJ	Class II	1985-01-23
K844250	Osada Enac	Osada Electric Co., Ltd.	ELC	Class II	1985-01-23
K844247	Ultrasonic Scanner Calibration & Test Phantoms	Technicare Corp.	GXX	Class I	1985-01-23
K844176	Premie Comfort Pad Patient & Infant Support Pads	Premie Comfort Products	FRP	Class I	1985-01-23
K844157	Holdster Arm Retention System	P.G.L. Medical			1985-01-23
K844120	Ultrasonic Scanner Calibration & Test Objects	Echo Ultrasound	GXX	Class I	1985-01-23
K844076	Electro-Nerve Stimulator B5/sk700b	BioMedical Life Systems Inc.	GZJ	Class II	1985-01-23
K844064	Medo Bubble Bath Ma-80, 400, 600 & 700	Medo U.S.A., Inc.	ILJ	Class II	1985-01-23
K844052	Biobrane Brand Temp. Wound Dressing W/adhesive	Woodroof Laboratories, Inc.			1985-01-23
K844048	Dr. Hessel's Insect Poison Remover	Medie Group	KYP	Class I	1985-01-23
K844034	Sonocare	Echo Ultrasound	DYO	Class I	1985-01-23
K843969	Model P23xl Physiological Pressure Transducer	Gould, Inc.	DXO	Class II	1985-01-23