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 2884 of 3529

510(k) clearances, page 2884 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K862621	I22 Initiales	Oticon, Inc.	ERA	Class I	1986-08-01
K862604	7200 Microprocess Vent Sys/model 7202 Display Opt	Medtronic, Inc.	CBK	Class II	1986-08-01
K862589	Ultratherm 808 I	Elmed, Inc.	IMJ	Class II	1986-08-01
K862533	Manual Surg. Instru. for Steinhauser Bone Plate	Biomet Microfixation	JEY	Class II	1986-08-01
K862523	Man Surg Instr/access Dumbach Titan Mesh Impl Sys	Biomet Microfixation	EKW	Class I	1986-08-01
K862513	External Ventricular & Lumbar Drainage Sets	Cordis US Corp.	JXG	Class II	1986-08-01
K862473	Pdq Amebiasis	Diamedix Corp.	KHW	Class II	1986-08-01
K862370	Dart Amylase-D.s. Reagent System	Coulter Electronics, Inc.	CIJ	Class II	1986-08-01
K862241	Standard Basin Kit Custom Basin Kit	Quali-Med, Inc.	FRG	Class II	1986-08-01
K862028	Ultrahesive II Postop Electrode	Medical Devices Inc.	GXY	Class II	1986-08-01
K861958	Replianalyzer	Mct Medical, Inc.	LON	Class II	1986-08-01
K861695	Surgical Plasters	Salvaplast Industries			1986-08-01
K861281	Microcor e.c.g. Monitor with A.c. Adapter	Microcor, Inc.	DPS	Class II	1986-08-01
K852331	Sys, Angiographic, Single-or Bi-Plane Radiographic	Scholten Surgical Instruments, Inc.	IZI	Class II	1986-08-01
K862760	Hearing Aid, Unitron Model Uf11	Unitron Industries, Inc.	ESD	Class I	1986-07-31
K862745	Eugenol Usp	E&D Dental Manufacturing Co.	EMB	Class I	1986-07-31
K862695	Fluor-Etch Gel Etchant	Teledyne, Inc.	EBC	Class II	1986-07-31
K862670	Rionet Hearing Aid Hb-35Pt	Rion Acoustic Instruments, Inc.	ESD	Class I	1986-07-31
K862667	Cobalt, 29.5% Chromium Alloy Dental Bake-on Alloy	Austenal Dental, Inc.	EJH	Class II	1986-07-31
K862660	Prisma Metal Opaquers	Dentsply Intl.	EBC	Class II	1986-07-31
K862653	Luer Lock Adapter/nut	Mallinckrodt Critical Care	FPA	Class II	1986-07-31
K862480	Bt Cath (Intravascular Catheter)	Baron Technologies, Inc.	FOZ	Class II	1986-07-31
K862410	Milex Kegel Perineal Exerciser	Milex Products, Inc.	HIR	Class II	1986-07-31
K862302	Blood Platelet Assay Method & Apparatus	Bellhouse Medical, Inc.	JOZ	Class II	1986-07-31
K861931	645Ob Sector/linear Ultrasound Scanner	GE Medical Systems Information Technologies, Inc.	HEM	Class II	1986-07-31
K861858	Vaginal Chamber Pellethane-Medical Grade 2363	Peritone Research, Ltd.	HIR	Class II	1986-07-31
K861539	Nikkiso Infusion Pump Model Pfa-02	International Medical Products, Inc.	FRN	Class II	1986-07-31
K861527	Comet Cosmic 203/218	Fuyo U.S.A. Co., Ltd.			1986-07-31
K862717	Hand Mirror (Endoscope)	Simpson/Basye, Inc.	GCO	Class II	1986-07-30
K862702	Tri-Lock II Titanium Acetabulum Prosthesis	Depuy, Inc.	LPH	Class II	1986-07-30
K862696	Temporary Hemo Clip, 07-096-01/02 & Apply Forcep	Downs Surgical, Ltd.	HBT	Class I	1986-07-30
K862664	Jedmed Ccd Camera System	JEDMED Instrument Company	FWD	Class I	1986-07-30
K862663	Tracheostomy Care Tray	Welmed Systems, Inc.	LRQ	Class I	1986-07-30
K862656	Pacemaker Lead Adapter	Cordis US Corp.	DTD	Class II	1986-07-30
K862582	Treace Medical Micro Instrument Wipe	Treace Medical, Inc.			1986-07-30
K862494	Polyester Sponge Pattie	American Silk Sutures, Inc.	HBA	Class II	1986-07-30
K862269	Laurier Santary Napkin (Modification)	Kao Corp.	HHD	Class I	1986-07-30
K861596	Acuson S519 Transducer	Acuson Computed Sonography	JOP	Class II	1986-07-30
K861579	Acuson L558 Transducer	Acuson Computed Sonography	JOP	Class II	1986-07-30
K861358	Ps System with Sd-200 Doppler	Johnson & Johnson Professionals, Inc.	ITX	Class II	1986-07-30
K860689	Spacelabs P.c. Cardiac Output/pressure Module	Spacelabs, Inc.	DSK	Class II	1986-07-30
K862741	Q50 Medical Treadmill	Quinton, Inc.	IOL	Class I	1986-07-29
K862738	Daniel Ortho Bed Lift Ac	Radco	ILK	Class II	1986-07-29
K862710	Kallestad Ssa/ssb Ena Test Reagents	Kallestad Laboratories, Inc.	LLL	Class II	1986-07-29
K862682	Mvp Generator, Catalog No. H8018	General Electric Co.	IZO	Class I	1986-07-29
K862652	Emit Valproic Acid Assay	Syva Co.	LEG	Class II	1986-07-29
K862541	Liquid Chromatography Columns	Supelco, Inc.	DPM	Class I	1986-07-29
K862506	The Waters Model 990 Photodiode Array Detector	EMD Millipore Corporation	KIE	Class I	1986-07-29
K862300	Amresco Flow Pac Sodium Potassium Reagent	Amresco, Inc.	JGM	Class II	1986-07-29
K862274	Analyst Analytical Test Rotors	E.I. Dupont de Nemours & Co., Inc.	CIC	Class II	1986-07-29