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 2329 of 3531

510(k) clearances, page 2329 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K925204	Beckman Diatrac Hemoglob A1c Electro Kit, Modified	Beckman Instruments, Inc.	LCP	Class II	1993-01-12
K925186	Equilibrium Radionuclide Angiocardioraphy Analysis	Strichman Medical Equipment, Inc.	KPS	Class II	1993-01-12
K924702	Turkel Abdominal Paracentesis System	Boston Scientific Corporation	GBX	Class I	1993-01-12
K924273	Accuflate	Instrumed, Inc.	KCY	Class I	1993-01-12
K923870	3Dtof Mra	Resonex, Inc.	LNH	Class II	1993-01-12
K923528	Inlet Irrigation/aspiration Valve and Probes	Inlet Medical, Inc.	GCJ	Class II	1993-01-12
K923518	Guiding Catheter	Interventional Therapeutics Corp.	DQY	Class II	1993-01-12
K923337	On*site Alcohol	Toxi-Lab, Inc.	DML	Class II	1993-01-12
K922409	Alm Illuminator Series Light System	Alm Surgical Equipment, Inc.	FSQ	Class II	1993-01-12
K922308	Tilghman Titanium Mesh Skeletal Orbit Liner	Ti-Mesh, Inc.	FTM	Class II	1993-01-12
K922062	The Denver Cautery	Denver Splint Co.	GEI	Class II	1993-01-12
K920910	Oxygen Powered Resuscitator for CPR	J. H. Emerson Co.	BTL	Class II	1993-01-12
K920909	Hexlock Screw	Imtec Corp.	DZE	Class II	1993-01-12
K915226	Isothermal Heated Ventilator & Anesthesia Circuit	Baxter Healthcare Corporation	BZE	Class II	1993-01-12
K925712	Reliance Short Stick Tie	Reliance Orthodontic Products, Inc.	DYX	Class II	1993-01-11
K925452	Dade Hepzyme	Baxter Diagnostics, Inc.	JBR	Class II	1993-01-11
K925404	Clearfil Porcelain Bond Activator	Kuraray Co.	KLE	Class II	1993-01-11
K925275	Soft Denture Reline Material Elastoline	Great Lakes Orthodontics, Ltd.	EBI	Class II	1993-01-11
K925259	CFR Monograph	Combe, Inc.	EFT	Class I	1993-01-11
K925001	Curity Calcium Alginate Wound Dressing	Kendall Healthcare Products Co. Div.Of Tyco Health	KMF	Class I	1993-01-11
K924856	Aia-Pack Prl Calibration Verification Test Set	Tosoh Medics, Inc.	JJX	Class I	1993-01-11
K924852	Asia-Pack Tsh Calibration Verification Test Set	Tosoh Medics, Inc.	JJX	Class I	1993-01-11
K924650	Gauze Sponges	Dav-Mar Medical Products, Inc.	NAB	Class I	1993-01-11
K924493	Document Total and Direct Bilirubin Linearity-Mod	Casco Standards	JJX	Class I	1993-01-11
K924091	Ebv-Vca Igg Elisa Test System	Zeus Scientific LLC	MCD	Class I	1993-01-11
K923384	Ana 70 Dispersed Phase Dental Alloy -- Modified	L.C. Dental	EJJ	Class II	1993-01-11
K922843	Dynarex Suction Catheters & Kits	Dynarex Corp.	BSY	Class I	1993-01-11
K922611	Scimed 6 Fr. Triguide - Elite Guiding Catheter	Scimed Life Systems, Inc.	DQY	Class II	1993-01-11
K913467	Toxogen	Biokit USA, Inc.	LLA	Class II	1993-01-11
K921347	Cepti-Seal Dressing Change Kit for Venous Catheter	Medi-Flex Hospital Products, Inc.	MCY	Class II	1993-01-08
K925254	Amo(r) Flrx-Tip(tm) Dispos I/a Handpiece, Opo-38	Advanced Medical Optics, Inc.	HQC	Class II	1993-01-07
K924926	Msi-Hct	Medical Specialties Inc.	GLK	Class II	1993-01-07
K924146	Oh-500 Oxygen Concentrator	Healthdyne, Inc.	CAW	Class II	1993-01-07
K922783	Es1700 ECG Modulator	Epic Systems Corporation	DXH	Class II	1993-01-07
K922665	Bivona Hyperflex Tracheostomy Tube	Bivona Medical Technologies	JOH	Class II	1993-01-07
K922645	Lsf Anatomic Cemented Hip	Osteo Technology, Inc.	JDI	Class II	1993-01-07
K921919	Ms-100 Myo-Scanner or Ms-100 EMG Scanner	Myo-Tronics, Inc.	KZM	Class II	1993-01-07
K920870	Angiographic Balloon Catheter by J Lloyd	J-Lloyd Medical, Inc.	DQO	Class II	1993-01-07
K920580	Transducer, Pressure, Catheter Tip	Greatbatch Medical	DXO	Class II	1993-01-07
K920082	Biochem Model 3301 Newox1 Oximeter	Biochem International, Inc.	DQA	Class II	1993-01-07
K914078	Depuy Hip Prosthesis	Depuy, Inc.	JDI	Class II	1993-01-07
K925998	Active Renin Immunoradiometric Assay	Nichols Institute Diagnostics	CIB	Class II	1993-01-06
K925189	Pregnagen 1-Step Pregnancy Test	Biogenex Laboratories, Inc.	LCX	Class II	1993-01-06
K924674	Direct Ldl Choles Immunoseparation Reagent	Genzyme Corporation	MRR	Class I	1993-01-06
K924195	Tracheostomy Care Set W/forceps & Gauze Trach Dres	American Healthcare Corp.	BTO	Class II	1993-01-06
K924194	Tracheostomy Care Set W/extra Towel(ahc-20-54686)	American Healthcare Corp.	BTO	Class II	1993-01-06
K923367	Cosgrove Edwards Annuloplasty System, Model 4600	Baxter Healthcare Corporation	KRH	Class II	1993-01-06
K922801	Resp. Panel 1 Indirect Immunofluorescence Assay	Light Diagnostics	GNY	Class I	1993-01-06
K922787	Echomark Guidewire with Ultrasonic Localization	Echocath, Inc.	DQX	Class II	1993-01-06
K922555	Enviromate(tm) Smoke Evacuation System	Lase, Inc.	FYD	Class II	1993-01-06