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 2026-10-22, 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 2960 of 3529

510(k) clearances, page 2960 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K852124	Hematocrit-Saturation Monitor Hsm-100	American Bentley	DRY	Class II	1985-09-16
K851913	Cordis High-Torque Temp. Pervenous Lead W/depth Ma	Cordis US Corp.	LDF	Class II	1985-09-16
K851732	Carbocone	Imtech Corp.	DRX	Class II	1985-09-16
K851450	Fluorescent Microbead Alignment Standards Tm	Flow Cytometry Standards Corp.	JIW	Class II	1985-09-16
K850946	Surgical Aspirator	Medicalex	BTA	Class II	1985-09-16
K852119	Temporary Pacemaker Ground Wire	Scholten Surgical Instruments, Inc.	DTB	Class III	1985-09-15
K853689	Precept Tm Moxalactam	Austin Biological Laboratories	LTW	Class II	1985-09-13
K853688	Precept Tm Tobramycin	Austin Biological Laboratories	LTW	Class II	1985-09-13
K853687	Precept Netilmicin 32-13	Austin Biological Laboratories	LTW	Class II	1985-09-13
K853686	Precept Tm Amikacin	Austin Biological Laboratories	LTW	Class II	1985-09-13
K853684	Precept Kanamycin	Austin Biological Laboratories	LTW	Class II	1985-09-13
K853394	600/L 5X6' Uva 85W Lamps, 5X5 Uva 65W Lamps 500/L	Interlab(Electromechanical)	FTC	Class II	1985-09-13
K853248	Challenger Sunrise	Challenge Products, Inc.	FTC	Class II	1985-09-13
K853058	Neos - M Abp	Biotronik Sales, Inc.	DXY	Class III	1985-09-13
K850833	Precept Tm Mezlocillin	Austin Biological Laboratories	JWY	Class II	1985-09-13
K844686	Ophthascan B	Biophysic Medical, Inc.	IYO	Class II	1985-09-13
K853611	Apl Xylose Lysine Deoxycholate Agar	Apl Medical Supplies	JSI	Class I	1985-09-12
K853609	Apl Tryptic Soy Broth	Apl Medical Supplies	JSD	Class I	1985-09-12
K853538	Cannula Clamp	Cp Medical	HXD	Class I	1985-09-12
K853537	Velcro Tourniquet	Cp Medical	GAX	Class I	1985-09-12
K853510	Minifilter Hemofilter	Amicon, Inc.	KDI	Class II	1985-09-12
K853486	Olympus Rigid Percutaneous Nephroscope	Olympus Corp.	FGA	Class II	1985-09-12
K853480	Skytron Elite 6000 & 6001 Surgical Tables	Skytron, LLC	GDC	Class I	1985-09-12
K853380	Spr 2 Autodiluter	Scientific Sales Intl., Inc.	JTC	Class I	1985-09-12
K853312	Argon Cut Biopsy Needles, Various Sizes	Argon Medical Corp.	DWO	Class I	1985-09-12
K853207	Pharm 100% Silicone Foley Cath Temperature Probe	American Pharmaseal Div. Ahsc	KOD	Class II	1985-09-12
K853206	Implant Program Cardiac Pulse Gen W/mod Set Screw	Telectronics, Inc.	DXY	Class III	1985-09-12
K853057	Trios - M	Biotronik Sales, Inc.	DXY	Class III	1985-09-12
K852746	External Pacemaker Telectronics Te200	Seamed Corp.	JOQ	Class II	1985-09-12
K852514	Model 78560A Central Station Patient Info Sys	Hewlett-Packard Co.	DSI	Class II	1985-09-12
K852360	Ortho DNA Probe Hsv Confirmation Test	Ortho Diagnostic Systems, Inc.	GQL	Class II	1985-09-12
K852128	Norelco Electronic Digital Bp Meter Hc3501	Philips Park	DXN	Class II	1985-09-12
K853591	Dialyzer, Capillary, Hollow Fiber	bioMerieux, Inc.	FJI	Class II	1985-09-11
K853559	Sterile Biopsy Needles	Plasmedics, Inc.			1985-09-11
K853535	Trauma Table	Xre Corp.	GDC	Class I	1985-09-11
K853369	H-H Fixation & Joining Connectors	Holter-Hausner Intl.	JXG	Class II	1985-09-11
K853367	H-H Burr Hole Catheter Support	Holter-Hausner Intl.	GXR	Class II	1985-09-11
K853366	H-H Unitized Standard Shunt/reservoir Shunt	Holter-Hausner Intl.	JXG	Class II	1985-09-11
K853346	Bear NICU-1	Bear Medical Systems, Inc.	BZK	Class II	1985-09-11
K853310	Simplex Enhancement Mixer	Howmedica Corp.	JDZ	Class I	1985-09-11
K853243	Visitec Irrigation Control System	Visitec Co.	KYG	Class I	1985-09-11
K852424	Acufex Comparative Surgical Keratometer	Acufex Microsurgical, Inc.	HJB	Class I	1985-09-11
K852322	Vsm-5	Physio Control, Inc.	DPS	Class II	1985-09-11
K851242	Greco-Harvey Surfactant Bonded Catheter for Gastro	Cook, Inc.	FGE	Class II	1985-09-11
K853452	Life Linc Patient Cable	Tronomed, Inc.	BZQ	Class II	1985-09-10
K852749	Recommended Alternative Dialyzer Disinfectant	Mesa Medical, Inc.	FKQ	Class II	1985-09-10
K851201	Medipart Lund Aerosol Kit Mp-1024A-M	Medipart Jerry Alexander	IYT	Class II	1985-09-10
K851200	Medipart Lung Aerosol Kit Mp-1024A	Medipart Jerry Alexander	IYT	Class II	1985-09-10
K851199	Medipart Lung Aerosol Kit Mp-1012A-M	Medipart Jerry Alexander	IYT	Class II	1985-09-10
K851198	Medipart Lung Aerosol Kit Mp-1012A	Medipart Jerry Alexander	IYT	Class II	1985-09-10