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 2026-10-15, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,969 of the 176,366 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	2,569

176,366 records, page 3142 of 3528

510(k) clearances, page 3142 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K832173	Gauze Sponge Sterile	Sudreca Surgical Dressings, Inc.	EFQ	Unclassified	1983-08-12
K832172	Gauze Sponge X-Ray Detectable-	Sudreca Surgical Dressings, Inc.	GDY	Class I	1983-08-12
K832163	Sopheia Digoxin Eia Kit	Siemens Healthcare Diagnostics Inc.	DPO	Class II	1983-08-12
K832140	Cryomedics 5000 Cryoprobes	Spembly Medical, Ltd.	GEH	Class II	1983-08-12
K832139	Tandem - E-Ckmb Immunoenzymetric Assay	Hybritech, Inc.	JHY	Class II	1983-08-12
K832137	Convertors Flash Sterilizing Tray	American Convertors Div., American Pharmaseal	FSM	Class I	1983-08-12
K832127	Nautilus Monoplace Hyperbaric Unit	Nautilus Environmedical Systems, Inc.	CBF	Class II	1983-08-12
K832126	Micro Z Dispos. Spinal Anesth. Needle	Smith & Nephew, Mpl Division	BSP	Class II	1983-08-12
K832124	Cpc, Couble Lumen Cardioplegia-Air Aspi	Med-West, Inc.	DWF	Class II	1983-08-12
K832123	Venipuncture Valve	Abbott Medical	FPA	Class II	1983-08-12
K832122	Enraf Nonivs2 Channel Emg/temp. Feed	Fluidotherapy Corp.	HCC	Class II	1983-08-12
K832120	Prominjet Pump	Abbott Medical	FRN	Class II	1983-08-12
K832110	Electrode Leads 030-267 & 030-268	Telectronics, Inc.	DTB	Class III	1983-08-12
K832103	Blood Tubing Set	Lee Medical Intl., Inc.	KOC	Class II	1983-08-12
K832098	N-Acetylprocainamide Assay for Cobas	Syva Co.	LAN	Class II	1983-08-12
K832075	Electronic Blood Press. Meter-Zh-820P	Panasonic Co. Div. Matsu Elec. Corp. America	DXN	Class II	1983-08-12
K832073	Electric Instrument Table	CooperVision, Inc.	HMF	Class I	1983-08-12
K832070	Amresco Na/k Reagent Set	American Research Products Co.	JGS	Class II	1983-08-12
K832051	Rim-Haemophilus 1 & 2	Austin Biological Laboratories	JST	Class I	1983-08-12
K832042	Lme Temp. Monitor	Litton Medical Electronics	FLL	Class II	1983-08-12
K832011	Ameri Clear	Stephens Scientific	KEM	Class I	1983-08-12
K832008	Infutrol 7000 Infusion Pump	Medtronic, Inc.	FRN	Class II	1983-08-12
K831976	Power Optic	Ritter GmbH	EAY	Class I	1983-08-12
K831963	Cryomedics Neurostat	Spembly Medical, Ltd.	GXH	Class II	1983-08-12
K831945	Elecath Baltherm Tlc Thermal Dilution	Electro-Catheter Corp.	DYG	Class II	1983-08-12
K831897	Beta I Programmable Infusion Pump	Orange Medical Instruments, Inc.	FRN	Class II	1983-08-12
K831883	Hearing Aid Unitron #Ue8-D	Unitron Industries, Inc.	ESD	Class I	1983-08-12
K831874	Lipase Reagent Set	Sterling Biochemical, Inc.	JGX	Class I	1983-08-12
K831873	Bone Screw	W. L. Gore & Associates, Inc.	HWC	Class II	1983-08-12
K831870	Allergenetics Fluoro-Fast Reader	Axonics, Inc.	JZT	Class I	1983-08-12
K831867	Pressure Monitoring IV Bottle Cap	Alto Development Corp	DRS	Class II	1983-08-12
K831840	Feeding Tube Placement Stylet	Biosearch Medical Products, Inc.	KNT	Class II	1983-08-12
K831823	Axiom Feeding Gastro Tube	Axiom Medical, Inc.	KNT	Class II	1983-08-12
K831793	Aqualizer Mouthpiece	Martin D. Lerman	KMY	Class I	1983-08-12
K831769	Various Cardiovascular Surgical Device	Research Industries Corp.	DWF	Class II	1983-08-12
K831761	Simplicity Plus	Critikon Company, LLC	FRN	Class II	1983-08-12
K831759	Intracardia Suckers	Research Industries Corp.	DWF	Class II	1983-08-12
K831727	Quarter Globe Caps	S. Jackson, Inc.	FTM	Class II	1983-08-12
K831724	Chin (Mentoplasty) Implants	S. Jackson, Inc.	FWP	Class II	1983-08-12
K831723	Supramid Extra Surgical Mesh	S. Jackson, Inc.	FTM	Class II	1983-08-12
K831659	Fogarty-Chin Peripheral Intraoperative	American Edwards Laboratories	LIT	Class II	1983-08-12
K831631	Gastrostomy Feeding Set	Plasco, Inc.	KNT	Class II	1983-08-12
K831614	Inspetoscope	Terayco Intl., Ltd.	ERA	Class I	1983-08-12
K831593	Maxi Shields	Weyerhaeuser Co.	HHD	Class I	1983-08-12
K831584	Bailey Aspirator/irrigator	Medical Instrument Development Laboratories, Inc.	HQE	Class II	1983-08-12
K831578	Physiological Monitor #902	Novametrix Medical Systems, Inc.	DRT	Class II	1983-08-12
K831566	Cui Mammary Prothesis Sizer	Cox-Uphuff Intl.	MRD	Unclassified	1983-08-12
K831526	Urine Total Protein Control	Quantimetrix Corp.	JJW	Class I	1983-08-12
K831506	Disp. Transducer W/monitoring Kit Trans	Sorensen Research	DRS	Class II	1983-08-12
K831486	Sc-603 Twin Valve	Instrumentation Industries, Incorporated	BTM	Class II	1983-08-12