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 2832 of 3529

510(k) clearances, page 2832 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K870458	Histones Eia Diagnostic Kit	Biohytech International, Inc.	DHN	Class II	1987-03-17
K870457	Rnp Eia Diagnostic Kit	Biohytech International, Inc.	LJM	Class II	1987-03-17
K870456	Dnp Eia Diagnostic Kit	Biohytech International, Inc.	LJM	Class II	1987-03-17
K870455	Sm Eia Diagnostic Kit	Biohytech International, Inc.	LJM	Class II	1987-03-17
K870452	Ss-DNA Eia Diagnostic Kit	Biohytech International, Inc.	LJM	Class II	1987-03-17
K870418	Mya-1 and Myt-1 Myelogram Tray	North Coast Medi-Tek			1987-03-17
K870376	Jimmy John III, Colonic Irrigation System	Colon Therapeutics	KPL	Class II	1987-03-17
K870348	Norfloxacin 10 Mcg Sensitivity Disks	Difco Laboratories, Inc.	JTN	Class II	1987-03-17
K870320	Dacomed Penile Prosthesis Sizer	Dacomed Corp.	JLW	Class II	1987-03-17
K870233	Cell-Dyn 1600 Multiparameter Auto. Hema. Analyzer	Abbott Diagnostics	GKZ	Class II	1987-03-17
K870127	Modified Jimmy John III	Colon Therapeutics	KPL	Class II	1987-03-17
K870089	Immunoscan(tm) Direct Neisseria Meningitidis Kit	Microscan Div. Baxter Healthcare Corp.	GTJ	Class II	1987-03-17
K870078	Accupen(r)	Ulster Scientific, Inc.	FMF	Class II	1987-03-17
K865063	Uni-Puls(tens) Model #292	Oms Medico, Inc.	GZJ	Class II	1987-03-17
K864848	Norfloxacin 10 Mcg Susceptibility Disk	bioMerieux, Inc.	JTN	Class II	1987-03-17
K864756	Norfloxacin 10 Mcg Sensi Disc	BD Becton Dickinson Vacutainer Systems Preanalytic	JTN	Class II	1987-03-17
K864696	Allerg*ens Enzyme Immunoassay Kit	Dexall Biomedical Labs, Inc.	DHB	Class II	1987-03-17
K864603	Deltatrac(tm) Metabolic Monitor	Datex Division Instrumentarium Corp.	BZL	Class II	1987-03-17
K864276	Personal Infusion Pump	Bionica, Inc.	FRN	Class II	1987-03-17
K864265	Hemodialysis Bath Concentrate Solutions for Hemodi	Dial Medical of Florida, Inc.	KPO	Class II	1987-03-17
K864200	Veta/vented Esophageal Tube Airway	Cranco Co.	CAO	Class II	1987-03-17
K863833	Body Watch Body Composition Analyzer Model 2010	Body Watch, Inc.	DSB	Class II	1987-03-17
K863298	Diamond Medical, Inc., Model Dm 700	Diamond Medical, Inc.	FFT	Class I	1987-03-17
K870818	Bodyscan	Siemens Gammasonics, Inc.	IYX	Class I	1987-03-16
K870755	Challenger Dosimeter	Salter Labs	CCQ	Class I	1987-03-16
K870619	Accelograph	Biometer Intl. A/S	BXN	Class II	1987-03-16
K870511	Chart-Type Micro Hematocrit Tube Reader	Norfolk Scientific, Inc.	JPI	Class II	1987-03-16
K870507	Grunwald Bi-Caval & Jones Bi-Caval Cannula	Research Medical, Inc.	DWF	Class II	1987-03-16
K870402	Mobilimb Hand Exerciser	Biodynamic Technologies, Inc.	BXB	Class I	1987-03-16
K870378	Abuscreen (R) Eia Barbiturate	Roche Diagnostic Systems, Inc.	DIS	Class II	1987-03-16
K870377	Abuscreen (R) Eia Cannabinoids	Roche Diagnostic Systems, Inc.	LDJ	Class II	1987-03-16
K870363	Haemoglobin Reagent - Cyanmethaemoglobin Method	Trace Scientific, Ltd.	KHG	Class II	1987-03-16
K870189	Aries Tapered Sheath	Aries Medical, Inc.	DYB	Class II	1987-03-16
K870171	(Merifluor)tm-Cryptosporidium	Meridian Diagnostics, Inc.			1987-03-16
K870109	Rmi Venous Drainage Cannula	Research Medical, Inc.	DWF	Class II	1987-03-16
K870027	Hand Held Pheumatic Powered (Disposable) Nebulizer	Salter Labs	CCQ	Class I	1987-03-16
K865104	Iq Fti Immunoassay	BD Becton Dickinson Vacutainer Systems Preanalytic	CEC	Class II	1987-03-16
K864955	Cytoscan	Image Recognition Systems, Ltd.	LNJ	Class II	1987-03-16
K864910	Mevacheck	Magus Microcontrollers, Inc.	IYE	Class II	1987-03-16
K864866	Resubmission of the Kleerzit Reagent	Advanced Biomedical Methods, Inc.	JKA	Class II	1987-03-16
K864843	Horizon 1100 Cardiac Monitor	Mennen Medical, Inc.	DPS	Class II	1987-03-16
K864719	Pflex Em(tm) (Exercise Monitor)	Health Products, Inc.	BWF	Class II	1987-03-16
K864436	Stavip 3000	Roseburg SA	JJN	Class I	1987-03-16
K864419	Lifewatch(r) Portable Monitoring System	Lifewatch Systems, Inc.	BZQ	Class II	1987-03-16
K864374	Argyle Sentinel Seal Autotransfusion System	Sherwood Medical Co.	CAC	Class II	1987-03-16
K864168	Morphine Roche (R) Eia Test	Roche Diagnostic Systems, Inc.	DOE	Class II	1987-03-16
K864131	Vision(tm) Crp	Abbott Medical	DCK	Class II	1987-03-16
K863843	Cocaine Metabolite Roche(r) Eia	Roche Diagnostic Systems, Inc.	DIO	Class II	1987-03-16
K870964	Esi-1002 System and Dc100s/c50m-P Transducer	Elscint, Inc.	IYO	Class II	1987-03-13
K870848	Schultz Metacarpal Component Driver	Warsaw Orthopedic, Inc.	HWR	Class I	1987-03-13