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 2026-10-15, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,969 of the 176,366 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	2,569

176,366 records, page 3138 of 3528

510(k) clearances, page 3138 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K832072	Vita-Mist Air Compressor & Nebulizer	Vita Medics	BTI	Class II	1983-09-12
K832065	Acuracy 071, Dental, Intraoral-X-Ray	Belmont Equipment Corp.	EAP	Class II	1983-09-12
K832058	Angio-Flo Contin-Arterial Flush Dev.	Parke-Davis Co.	KRA	Class II	1983-09-12
K832047	Sterile Suture Removal Set	Ormed Mfg., Inc.	KDD	Class I	1983-09-12
K831998	Birthwell Birthing System	Qulab Co.	KNC	Class II	1983-09-12
K831965	Creatine Kinase Reagent Ck Lts	Electro-Nucleonics Laboratories, Inc.	CGS	Class II	1983-09-12
K831934	Theophylline Test Pack Aca	E.I. Dupont de Nemours & Co., Inc.	KLS	Class II	1983-09-12
K831915	Safety Pins & Rubber Bands	Ormed Mfg., Inc.	KDC	Class I	1983-09-12
K831911	Disposable Floor Instruments	Ormed Mfg., Inc.	KDC	Class I	1983-09-12
K831886	Femoral Canal Sponge	Zimmer GmbH	NAB	Class I	1983-09-12
K831875	Balloon Dilation Helical Stone Extract	Vpi	FFL	Class II	1983-09-12
K831816	Protex Contracept Plus W/sperm-Lub	National Sanitary Laboratories, Inc.	HIS	Class II	1983-09-12
K831788	Urodynamic Analyzer	C.R. Bard Inc	FAN	Class II	1983-09-12
K831780	Metabolic Exercise Testing System	Warren E. Collins, Inc.	BZL	Class II	1983-09-12
K831764	Urias Pressure Splints, & First Aid	Svenol Andersen	FZF	Class I	1983-09-12
K831743	Sterile Foley Catheters & Urological	Electromedics, Inc.	KOD	Class II	1983-09-12
K831667	Feminine Hygiene Device	Snow Willow Co.	HED	Class I	1983-09-12
K831665	Disposable Needle Holder	Medcare Products	KDC	Class I	1983-09-12
K831664	Plastic Thumb Forceps	Medcare Products	KDC	Class I	1983-09-12
K831651	Evoked Potential System 2000	Ophthalmetric Corp.	GWE	Class II	1983-09-12
K831650	Anesthesia/respiratory Disconnect -	Plasmedics, Inc.	BZQ	Class II	1983-09-12
K831534	Pumpette As8p-Infusion Pump	Travenol Laboratories, S.A.	FRN	Class II	1983-09-12
K831522	Bio-Tek Percent Oxygen Monitor 74222	Bio-Tek Instruments, Inc.	CCL	Class II	1983-09-12
K831503	Downs Adjustable Flow Generator	Vital Signs, Inc.	BYE	Class II	1983-09-12
K831445	Infusion Sets #'S 124 & 142 Personal	Pacesetter Systems	FPA	Class II	1983-09-12
K831444	Single Use Syringe #103 Personal Medic	Pacesetter Systems	FRN	Class II	1983-09-12
K831430	Air Shields as-100 Monioring Sys-As105	Narco Scientific	DRT	Class II	1983-09-12
K831422	Bioflow	Bomed Medical Mfr., Ltd.	DSB	Class II	1983-09-12
K831421	Bomed Biocon	Bomed Medical Mfr., Ltd.	DSB	Class II	1983-09-12
K831255	Laryngoscope Attachment Ph2000	Eder Instrument Co, Inc.	EQN	Class II	1983-09-12
K831215	Dentacolor Light Curing Crown & Bridge	Kulzer GmbH	EBF	Class II	1983-09-12
K831077	Dentalon	Kulzer GmbH	EBG	Class II	1983-09-12
K831004	Automated 8400 Blood Cell Separator	Intl. Business Machines	LKN	Unclassified	1983-09-12
K830389	Accu-Rynge Pump Sp-250	Delta Medical Industries	FRN	Class II	1983-09-12
K831977	C Tec Series 9000 e.c.g. Electrode	Speywood Medical, Ltd.	DRX	Class II	1983-09-09
K831885	Code Blue Manual Resuscitator	Vital Signs, Inc.	BTM	Class II	1983-09-08
K831600	Diastix Reagent Strips for Urinalysis	Miles Laboratories, Inc.	JIL	Class II	1983-09-08
K832565	Ohio 5400 Volume Monitor	Airco/Ohio Medical Products	BZK	Class II	1983-09-01
K832420	Facs Analyzer	BD Becton Dickinson Vacutainer Systems Preanalytic	GKL	Class II	1983-09-01
K832419	A-Gent Pherytoin	Abbott Medical	DIP	Class II	1983-09-01
K832381	Corning Magic Single Step Free T4	Corning Medical & Scientific	CEC	Class II	1983-09-01
K832365	Tcbs Agar	Granite Diagnostics, Inc.	JSI	Class I	1983-09-01
K832357	Aca Total Bilirubin Analytical Test Pak	E.I. Dupont de Nemours & Co., Inc.	CIG	Class II	1983-09-01
K832333	Feedback EMG System Pe-020	Bio-Feedback Systems, Inc.	HCC	Class II	1983-09-01
K832314	Cardizyme Plus Ld #65094/93	Em Industries, Inc.	CFE	Class II	1983-09-01
K832313	Magic Tsh 125I Radioimmunoassay	Corning Medical & Scientific	JLW	Class II	1983-09-01
K832310	Rogosa Broth	Oxoid U.S.A., Inc.	JSD	Class I	1983-09-01
K832297	Hydroxyprogesterone-17	Diagnostics Biochem Canada, Inc.	JLS	Class I	1983-09-01
K832292	Solo-Tach	Dentsply Intl.	DYH	Class II	1983-09-01
K832288	Hemoglobinometer	Mallinckrodt Critical Care	KMG	Class II	1983-09-01