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 1927 of 3531

510(k) clearances, page 1927 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K961968	Bblcrystal Gram-Positive Id System	BD Becton Dickinson Vacutainer Systems Preanalytic	LQL	Class I	1997-02-04
K961730	Rapid Gram-Positive Id System	Becton Dickinson Microbiology Systems	LQL	Class I	1997-02-04
K961024	Biosign Mono-Plus Wb,biosign Mono Wb,mono-Plus Wb,accusign Mono Wb	Princeton BioMeditech Corp.	KTN	Class II	1997-02-04
K960850	Access Chlamydia Assay	Bio-Rad Laboratories Inc.	LJC	Class I	1997-02-04
K953976	Safe Micro	Polystan A/S	DTZ	Class II	1997-02-04
K964933	Mekanika's Spinal Stiffness Gauge (Ssg)	Mekanika, Inc.	LBB	Class II	1997-02-03
K964851	Entracare Thermomter Model 1000	Entracare Corp.	FLL	Class II	1997-02-03
K964743	Storz E8010 Ergotec/premiere Adaptor	Storz Instrument Co.	HQE	Class II	1997-02-03
K964662	Favc: Femoral Artery Vascular Clamp - Model Number Rmds 1000-15, Rmds 1000-20, Rmds 2000-15, Rmds 2000-20, Rmds 3000-15	Rmds, Inc.	DXC	Class II	1997-02-03
K964532	Multitak Ss Suture System	Bonutti Research, Inc.	MBI	Class II	1997-02-03
K964472	Riopro Cobalt Trapeziometarcarpal Resurfacing Component	Biologically Oriented Prostheses	KYI	Class II	1997-02-03
K964468	Iamin Wet Dressing (Copper-Saline)	Procyte Corp.	MGQ	Unclassified	1997-02-03
K964426	Smartoae	Intelligent Hearing Systems Corp.	EWO	Class II	1997-02-03
K964137	Rta Retinal Thickness Analyzer	Talia Technology, Ltd.	HLI	Class II	1997-02-03
K964028	Sys Stim 226	Mettler Electronics Corp	IPF	Class II	1997-02-03
K963671	Osteonics Flanged Polyethylene Acetabular Cup	Osteonics Corp.	JDI	Class II	1997-02-03
K963248	Flow Directed Thermodilution/infusion Balloon Catheter (575-110P)	J-Lloyd Medical, Inc.	DYG	Class II	1997-02-03
K962942	Totalcare	Hill-Rom Inc.	FNL	Class II	1997-02-03
K962468	Hedrocel Acetabular Restrictor	Implex Corp.	JDI	Class II	1997-02-03
K965060	Ultra-Etch Stat	Ultradent Products Inc.	EBF	Class II	1997-01-31
K964390	Chase Vessel Occluder	Chase Medical, Inc.	MJN	Class II	1997-01-31
K964386	Radionics Contour Flex Plus Valve	Radionics, Inc.	JXG	Class II	1997-01-31
K964371	Shunt Tap with Icp Monitoring Access Port	Integra Neurocare, LLC	JXG	Class II	1997-01-31
K963765	Stryker Strykeflow Electrocautery Probes	Stryker Corp.	GEI	Class II	1997-01-31
K963580	Imagyn Falloposcopy System	Imagyn Medical, Inc.	MKO	Class II	1997-01-31
K962587	Conceptus Fallopian Tube Catheteization with Microendoscopy System	Conceptus, Inc.	MKO	Class II	1997-01-31
K970146	Elecsys Calcheck Testosterone	Boehringer Mannheim Corp.	JJX	Class I	1997-01-30
K970016	Vitros Immunodiagnositcs Products-Free T3 Reagent Pack (Gem.1020)/free T3 Calibrators (Gem.c020)	Johnson & Johnson Clinical Diagnostics, Inc.	CDP	Class II	1997-01-30
K965105	Electrophysiology Tilt Table Model #9660	U.S. Imaging Tables, Inc.	IXR	Class II	1997-01-30
K964612	Vistakon (Genfilcon a) Contact Lens, Clear and with Visibiliity Tint	Vistakon, Johnson & Johnson Vision Products, Inc.	LPL	Class II	1997-01-30
K964529	Cw Acupuncture Needles	Lhasa Medical, Inc.	MQX	Class II	1997-01-30
K964456	Polyfin Qr with Wings Infusion Sets, Models 365, 366, and 367	Medtronic, Inc.	FPA	Class II	1997-01-30
K964455	Polyfin with Wings Infusion Sets, Models 306, 307, 333	Medtronic, Inc.	FPA	Class II	1997-01-30
K964445	Octopus Tissue Stabilizer (28001/28002/28003/28004/28005/28006)	Dlp, Inc.	DWS	Class I	1997-01-30
K964436	Western Surgical Reusable Laparoscopic Trocar System	Western Surgical Instrument Co.	HET	Class II	1997-01-30
K964367	Ces Vascular Occlusion System	Cordis Neurovascular, Inc.	HCG	Class II	1997-01-30
K964363	BIPAP Duet System	Respironics, Inc.	BZD	Class II	1997-01-30
K964141	Ge Sterile Disposable Equipment Coil Cover	Domico Med-Device, LLC	MOS	Class II	1997-01-30
K964041	Cutaneous Compression Device for Use in Hemodialysis	Robert R. Stevens	KOC	Class II	1997-01-30
K963764	Specialty T Toric (Ocufilcon a) Contact Lens for Daily Wear	Specialty Ultravision, Inc.	LPL	Class II	1997-01-30
K962813	Dextren Clear Powder-Free Hypoallergenic Surgical Gloves	Maxxim Medical	KGO	Class I	1997-01-30
K962288	Cover-All, Drape-It-All, Chair Sleve, X-Ray Sleeve, Headrest Cover	Pinnacle Products, Inc.	MMP	Class II	1997-01-30
K961975	Disetronic D-Modem	Disetronic Medical Systems	FRN	Class II	1997-01-30
K961521	Patient Examination Glove	Shanghai PT Plastics Enterprise Company, Ltd.	LYZ	Class I	1997-01-30
K954674	P1op2b or P1o92t	Kay Borch A/S	FYA	Class II	1997-01-30
K953938	Sterilemax	Barnstead/Thermolyne Corp.	FLE	Class II	1997-01-30
K964744	Senna	Trans-America Enterprises Corp.	HQY	Class I	1997-01-29
K964564	Sunglasses	Micron Metal & Plastic Manufactory Co.	HQY	Class I	1997-01-29
K964379	Ksea Puncture Cannula	Karl Storz Endoscopy-America, Inc.	HET	Class II	1997-01-29
K964366	Eagle Eyes	Mech-Tronic Precision Mfg., Ltd.	HQY	Class I	1997-01-29