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 2026-10-21, 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 3013 of 3529

510(k) clearances, page 3013 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K850155	ECG Patient Monitor 302	Rigel Medical Electronics, Inc.	DRT	Class II	1985-03-01
K850034	Kotex Thin Maxi Pads	Kimberly-Clark Corporation	HHD	Class I	1985-03-01
K850033	Kotex Maxi Pads	Kimberly-Clark Corporation	HHD	Class I	1985-03-01
K850007	Acoustic Otocope Recorder	Endeco Medical, Inc.	ETY	Class II	1985-03-01
K844882	Rico Rs-6X Emergency Medical Aspirator	Rico Suction Laboratories, Inc.	GCX	Class II	1985-03-01
K844881	Rico Rs4-Xp Emergency Medical Aspirator	Rico Suction Laboratories, Inc.	GCX	Class II	1985-03-01
K844848	Ima-Trol Immunoassay Control	Dimension Diagnostics	JJY	Class I	1985-03-01
K844589	Osmolarity Standards	Rna Medical Corp.	JMZ	Class I	1985-03-01
K844549	Head-Spine Stabilizer Hss-1	Imaging Accessories, Inc.	IWY	Class I	1985-03-01
K844298	Adac Model Dps-3300M Digital Processing System	Philips North America LLC	LLZ	Class II	1985-03-01
K844218	Tomographic Gantry	General Electric Co.	IYX	Class I	1985-03-01
K844037	Digital Fluorographic Imaging System Digiformer	Toshiba Medical Systems	LLZ	Class II	1985-03-01
K843443	Edec-100	Electromed Intl., Ltd.	IZO	Class I	1985-03-01
K842976	Brentwood Ez Scan 200 Ambulatory ECG	Brentwood Instruments, Inc.	DSI	Class II	1985-03-01
K842944	Monitoring System M720	Burdick Corp.	DPS	Class II	1985-03-01
K842538	Accutorr Csm System	Datascope Corp.	DXN	Class II	1985-03-01
K842514	Electrocardiogram Dispos. Electrode Pad	Multi Biosensors, Inc.	DRX	Class II	1985-03-01
K842067	Calculating Cuff Inflator Td312	D. E. Hokanson, Inc.	DXN	Class II	1985-03-01
K842051	EKG Transmitter Model 5134	Instromedix, Inc.	DXY	Class III	1985-03-01
K842037	Ls 5	Life Science Instrumentation, Inc.	DRT	Class II	1985-03-01
K841944	Disposable ECG Electrode	Bristol Medical Electronics Corp.	DRX	Class II	1985-03-01
K840169	Phonoangiographic Spectral Analyzer	Biotronics Instruments	DPW	Class II	1985-03-01
K850493	Sunshower Model Hu-01-12L	Sunthetic Engineering, Inc.	FTC	Class II	1985-02-28
K850312	Gynaspyr Vacuum Curettage Unit	Roseburg SA	HHI	Class II	1985-02-28
K850297	Electrosurgical Pencil Holder 720	Birtcher Corp.	GEI	Class II	1985-02-28
K850286	Mentor Percutaneous Coil Nephrostomy Set	Mentor	LJE	Unclassified	1985-02-28
K850285	Gent-L-Kare Sterile Urethral Catheterization Tray	Premium Plastics, Inc.	KOD	Class II	1985-02-28
K850251	Rotalok Surgical Hand Table	Fairleigh Dickinson Laboratories, Inc.			1985-02-28
K850179	Mbm(tm) Monitral (R) Bicarbonate Module	Hospal Medical Corp.	FKP	Class II	1985-02-28
K850176	Mentor Dbl-Coil Indwelling Polyurethane Ureteral-	Mentor	FAD	Class II	1985-02-28
K850133	Veni-Gard Ap & Tpn, Derma-Shield, Derma-Shield Jr.	Consolidated Medical Equipment Company	KGX	Class I	1985-02-28
K850129	Modified Conductive Adhesive Electrosurgical Groun	Consolidated Medical Equipment Company	GEI	Class II	1985-02-28
K844993	Cohen-Warner Testicular Biopsy Tray 2N2720	Omnis Surgical, Inc.	FCG	Class II	1985-02-28
K844478	Hearing Aids Models Ims, Isd, Icl & Ihx	The Ite Co.			1985-02-28
K844246	Nethery Extremity Freezing Unit	Howard J. Nethery & Assoc.	GEH	Class II	1985-02-28
K850534	Bsi Model Mct 7000-Thermal Imaging System	Bales Scientific, Inc.	LHQ	Class I	1985-02-27
K850526	Ebss W/o Ca & Mg-Earle's Balanced Salt Solution	Mediatech, Inc.	KIT	Class I	1985-02-27
K850525	Dpbs-Dulbecco's Phosphate Buffered Saline	Mediatech, Inc.	KIT	Class I	1985-02-27
K850524	Hbss-Hanks' Balanced Salt Solution	Mediatech, Inc.	KIT	Class I	1985-02-27
K850523	Ebss-Earle's Balance Salt Solution	Mediatech, Inc.	KIT	Class I	1985-02-27
K850522	Mem Vitamins-Minimum Essential Medium Vitamins	Mediatech, Inc.	KIT	Class I	1985-02-27
K850521	Mem Aa-Minimum Essential Medium Amino Acids	Mediatech, Inc.	KIT	Class I	1985-02-27
K850520	Neaa-Non-Essential Amino Acids	Mediatech, Inc.	KIT	Class I	1985-02-27
K850519	Glutamine-1-Glutamine	Mediatech, Inc.	KIT	Class I	1985-02-27
K850518	Na Pyruvate-Sodium Pyruvate	Mediatech, Inc.	KIT	Class I	1985-02-27
K850517	Med. 199 W/earle's Salts-Medium 199 W/earles Salts	Mediatech, Inc.	KIT	Class I	1985-02-27
K850516	Ham's F-12-a Spedific Formulation Form Dr. Ham	Mediatech, Inc.	KIT	Class I	1985-02-27
K850515	Ham's F-10-a Spec. Formulation from Dr. Ham	Mediatech, Inc.	KIT	Class I	1985-02-27
K850514	Alpha Mem-Alpha Minimum Essential Med. W/o Ribosid	Mediatech, Inc.	KIT	Class I	1985-02-27
K850513	Rpmi 1640-Roswell Park Memorial Institute 1640	Mediatech, Inc.	KIT	Class I	1985-02-27