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 2327 of 3531

510(k) clearances, page 2327 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K924048	Cabot Disposable 10Mm Suction Device	Cabot Medical Corp.	GCJ	Class II	1993-01-22
K923928	Bipolar Coagulator/irriagation System	Valley Forge Scientific Corp.	GEI	Class II	1993-01-22
K923577	Breast Shells	Medela AG	HFS	Class I	1993-01-22
K923302	Tenderlett Finger	Accriva Diagnostics, Inc.	FMK	Class II	1993-01-22
K922972	Models 438-05 and 435-05 Implantable Pacing Lead	Intermedics, Inc.	DTB	Class III	1993-01-22
K922810	Odyssey	O-Two Systems Intl., Inc.	BTM	Class II	1993-01-22
K922074	Dcr Volumetric Infusion Pump W/ New Mains Power Pk	Danby Medical, Ltd.	FRN	Class II	1993-01-22
K920822	Cardiovascular Permanent Pacemaker Electrode	Siemens-Pacesetter, Inc.	DTB	Class III	1993-01-22
K920333	Smartdop 20 Bi-Directional Blood Flow Detector	Koven and Assoc., Inc.	DPW	Class II	1993-01-22
K915251	Patient Examination Latex Gloves, Hypoallergenic	Supermax Sdn Bhd	LYY	Class I	1993-01-22
K914520	Diomed 25 Surgical Diode Laser, Urology Applicat	Dio-Med Corp.	GEX	Class II	1993-01-22
K926069	Wrist Traction	Octostop, Inc.	KPR	Class II	1993-01-21
K926056	9600 Fluoroscopic Imaging System	Oec-Diasonics, Inc.	OXO	Class II	1993-01-21
K925785	Autostat Anti-Thyroid Microsomal Kit	Cogent Diagnotics, Ltd.	JZO	Class II	1993-01-21
K925784	Autostat Antithyroglobin	Cogent Diagnotics, Ltd.	JZO	Class II	1993-01-21
K925344	Coulter New Meth Blue Preprep Retic/maxm W/autoloa	Coulter Corp.	GKZ	Class II	1993-01-21
K925284	Imagessshare 910	Dejarnette Research Systems	LMD	Class I	1993-01-21
K924953	Fluid Cooled Bone Saw Blade, 6000 Series	Boehringer Laboratories, LLC	GFA	Class I	1993-01-21
K924934	Automatic Impedance Meter Ae-205	American Electromedics Corp.	ETY	Class II	1993-01-21
K924933	Ae-206 Tympnomwrwe(r) Audiometer	American Electromedics Corp.	ETY	Class II	1993-01-21
K924458	Ai5200 Diag Ultra Sound Syst Includ 7.5 & 10.0 Mhz	Acoustic Imaging Technologies Corp.	IYO	Class II	1993-01-21
K924310	Prestilix 1694 D Image Intensified Fluorosccopic	GE Healthcare	LLZ	Class II	1993-01-21
K924116	Medrad Mct, Mct Plus Injector/medrad Front Load	Medrad, Inc.	DXT	Class II	1993-01-21
K923783	Ethyl Alcohol Assay	Diagnostic Reagents, Inc.	DMT	Class II	1993-01-21
K923761	Itc Microsample Coagulation Analyzer System	Accriva Diagnostics, Inc.	JPA	Class II	1993-01-21
K923681	Exonox Percutaneous Introducer System W/ Hemostasi	Exonix Research Corp.	DYB	Class II	1993-01-21
K923597	Synthes Titanium Unreamed Femoral Nail	Synthes (USA) Products LLC	HSB	Class II	1993-01-21
K923580	Synthes Ti-6Ai-7Nb Unreamed Femoral Nail	Synthes (USA) Products LLC	HSB	Class II	1993-01-21
K923307	Healthpak X-Ray Sox Barriers	Healthpak, Inc.	EAP	Class II	1993-01-21
K923141	Philips Pre-Filter Option	Philips North America LLC	ITY	Class I	1993-01-21
K922164	Raytel Digital Imaging Systems	Olicon Imaging Systems, Inc.	LMD	Class I	1993-01-21
K922145	Sinoject Maxillary Sinus Puncture & Irrigation Sys	Atos Medical AB	KAM	Class I	1993-01-21
K922126	Hospital Kit ENT 1125	Savoy Medical Supply Co., Inc.	LRP	Class I	1993-01-21
K921412	Microprotein Reagent Set	Sterling Diagnostics, Inc.	CEK	Class II	1993-01-21
K921291	Inman Medical Packing Strip	Inman Medical Corp.	FER	Class II	1993-01-21
K920745	Nutex Gloves	Ansell Intl.	KGO	Class I	1993-01-21
K920546	Paragon Posterior Spinal System	Sofamor Danek Mfg., Inc.	KWP	Class II	1993-01-21
K914934	Hand Pack	Westmark Hospital Supplies	KDO	Class II	1993-01-21
K925747	Dryslide(tm) Indole	Difco Laboratories, Inc.	JTO	Class I	1993-01-15
K925693	Ez View	Difco Laboratories, Inc.	MDB	Class I	1993-01-15
K925644	Cation Adjusted Mueller Hinton Broth	Pasco Laboratories, Inc.	JWY	Class II	1993-01-15
K925569	Ax-700Le Automatic X-Ray Film Processor	Alphatek Corp.	IXW	Class II	1993-01-15
K925421	Endosheath	Cogentix Medical, Inc.	EOB	Class II	1993-01-15
K925212	Giotto Patient Bed	Gold Coast Imaging, Inc.	IZH	Class II	1993-01-15
K925173	Boomerang Turbinate Glove and Septal Splint	Westmed Intl.	LYA	Class I	1993-01-15
K925107	Smt-50Xm Magnetic Resonance Imaging System	Shimadzu Medical Systems	LNH	Class II	1993-01-15
K925097	Vortech's Autorouter (Automatic Image Routing)	Vortech Data, Inc.	LMD	Class I	1993-01-15
K924980	Cathscanner Visions Microrail Ultra Imag Cath	Endosonics Corp.	ITX	Class II	1993-01-15
K924893	Microsporidium Control Slide	Scientific Device Laboratory, Inc.	LJG	Class I	1993-01-15
K924878	New Detector Option	Philips North America LLC	IYX	Class I	1993-01-15