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 1851 of 3531

510(k) clearances, page 1851 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K974322	Abca-Nt Gas Isotope Ratio Mass Spectrometer System	Europa Scientific, Ltd.	DOP	Class I	1997-12-16
K974254	Benefit B3--- Series	M.C. Healthcare Products, Inc.	FNL	Class II	1997-12-16
K974175	Heartport Endoaortic Clamp Catheter	Heartport, Inc.	DWZ	Class II	1997-12-16
K973919	Cavity Varnish (Intermediary Varnish and Dentinal Tubuli Seal)	Medental Intl.	LBH	Class II	1997-12-16
K973818	T-Rex Biopsy Forceps	Boston Scientific Corporation	DWZ	Class II	1997-12-16
K973803	Flexview CO2 Blower with Mist	Ethicon Endo-Surgery Inc	FQH	Class II	1997-12-16
K973699	Ultralon Powder Free Latex Surgical Glove	Johnson & Johnson MEDICAL GmbH	KGO	Class I	1997-12-16
K973676	Prestige Aqueous Glucose Control Low, Prestige Aqueous Glucose Control High	Sorrento Biochemical, Inc.	JJX	Class I	1997-12-16
K973552	Ocu-Guard Orbital Implant Wrap, Supple Ocu-Guard Orbital Implant Wrap	Bio-Vascular, Inc.	MTZ	Class II	1997-12-16
K973538	N-Terface	Winfield Laboratories, Inc.	MGP	Unclassified	1997-12-16
K973525	Maurice Worldwide Shunt System	Integra Neurocare, LLC	JXG	Class II	1997-12-16
K973511	Kendall Curity Petrolatum Gauze	Kendall Healthcare Products Co. Div.Of Tyco Health	FRO	Unclassified	1997-12-16
K972843	Protos Blood Transfusion Set	Globe Ent., Inc.	BRZ	Class II	1997-12-16
K972698	Tof-Watch	bioMerieux, Inc.	KOI	Class II	1997-12-16
K972473	One Touch II Hospital Blood Glucose Monitoring System Data Dock	Lifescan, Inc.	CGA	Class II	1997-12-16
K971118	Arago	Premier Laser Systems, Inc.	GEX	Class II	1997-12-16
K970714	Stryker Constavac Blood Conservation System II (Cbcii)	Stryker Corp.	CAC	Class II	1997-12-16
K965008	Birthnet II Perinatal Patient Data Management System	GE Healthcare	HGM	Class II	1997-12-16
K963659	Exel i.v. Administration Set	Exel Intl.	FPA	Class II	1997-12-16
K974211	Opus 2 - Full Concha Series - Ite	Bernafon-Maico, Inc.	ESD	Class I	1997-12-15
K974152	Opus 2 - Completely-in-Canal Series (Cic)	Bernafon-Maico, Inc.	ESD	Class I	1997-12-15
K974069	Opus 2 - Canal Series (Itc)	Bernafon-Maico, Inc.	ESD	Class I	1997-12-15
K973932	Beckman Calibrator 2 (Cal2)	Beckman Instruments, Inc.	JIX	Class II	1997-12-15
K973678	Ultra + Aqueous Gluclose Control Low Ultra + Aqueous Glucose Control High	Sorrento Biochemical, Inc.	JJX	Class I	1997-12-15
K973677	Diascan Aqueous Glucose Control Low, Diascan Aqueous Glucose Control High	Sorrento Biochemical, Inc.	JJX	Class I	1997-12-15
K973662	Accu-Chek(r)complete System/meter & Accu-Chek Advantage Test Strips/accu-Chek Advantage H Test Strips	Boehringer Mannheim Corp.	LFR	Class II	1997-12-15
K973507	Kendall Xeroform Petrolatum Dressing (6311,6312,6313,6314,6315,6316,6317)	Kendall Healthcare Products Co. Div.Of Tyco Health	FRO	Unclassified	1997-12-15
K973008	Courier St Balloon Dilatation Catheter	Boston Scientific Corporation	FGE	Class II	1997-12-15
K974518	Non-Sterile Powder-Free Latex Examination Gloves Colored	Yty Industry (Manjung) Sdn. Bhd.	LYY	Class I	1997-12-12
K974340	Unitron Model Sound F/xp Programmable Mini Bte	Unitron Industries, Inc.	ESD	Class I	1997-12-12
K974339	Unitron Model Sound F/xd Programmable	Unitron Industries, Inc.	ESD	Class I	1997-12-12
K974338	Unitron Model F/x Programmable (Mini Bte)	Unitron Industries, Inc.	ESD	Class I	1997-12-12
K974286	Circumcision Tray, Cat. No. 70340	Trinity Laboratories, Inc.	HFX	Class II	1997-12-12
K974257	Resound Digital 2000-Bt W/digital 2000-Df (Digital Programmer)	Resound Corp.	ESD	Class I	1997-12-12
K974228	Hospital's Spec	Gps	HIB	Class II	1997-12-12
K974227	Hospital's Clamp	Gps	HFW	Class II	1997-12-12
K974129	Hi-69E, Hi-69N, Hi-69P	Rockwin Corp.	ESD	Class I	1997-12-12
K974081	Resound Stealth Cic	Resound Corp.	ESD	Class I	1997-12-12
K974007	Shah Permavent	Exmoor Plastics Limited	ETD	Class II	1997-12-12
K973965	Smart Motorized Viewer	Smartlight, Inc.	IXC	Class I	1997-12-12
K973950	Retinal Cube	Applied Spectral Imaging, Ltd.	HKI	Class II	1997-12-12
K973942	Swift Delivery Product #300	Swift Delivery Products	HDB	Class II	1997-12-12
K973737	Mini Trocar Sleeve and Trocars 3.5 Mm, Micro Trocar Sleeve and Trocars 2 Mm, Dilatation Sleeve and Guide Rod 2 Mm to 3.M	Richard Wolf Medical Instruments Corp.	HET	Class II	1997-12-12
K973712	Minxray Hf100h High Frequency Diagnostic X-Ray Unit	Minxray Inc	IZL	Class II	1997-12-12
K973653	Seemor - Display & Processing Program Executing on Personal Computer System	Areeda Assoc., Ltd.	LLZ	Class II	1997-12-12
K973524	Advance Modular Tibial Component	Wrightmedicaltechnologyinc	JWH	Class II	1997-12-12
K973494	Hi-Torque Balance Guide Wire with Hydrocoat Hydrophilic Coating, Acs Hi-Torque Balance Middleweight Guide Wire with Hydg	Boston Scientific Corporation	DQX	Class II	1997-12-12
K972365	Compact or Comp-X	Eurotec, S.r.l.	IZL	Class II	1997-12-12
K971905	Dako Mouse Anti Human Cytokeratin, High Molecular Weight, Clone 34Be12, Monoclonal Antibody for Immunoenzymatic Staining	Dako Corp.	DEH	Class II	1997-12-12
K971528	Endoscopically Deliveralbe Ultrasound Point Porbe System (Endoscopy)	FUJIFILM Healthcare Americas Corporation	IYO	Class II	1997-12-12