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 2374 of 3531

510(k) clearances, page 2374 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K914231	Elpha 2000	Biometer Intl. A/S	IPF	Class II	1992-05-28
K914092	Bsm-2100A Configured Patient Monitor	Nihon Kohden America Inc	DSI	Class II	1992-05-28
K922224	Otosonic Acs-Ic	Beltone Electronics Corp.	ESD	Class I	1992-05-27
K922140	Orthoderm Convertible II	Bio Clinic Co.	IOQ	Class II	1992-05-27
K920268	3M Digital Disk Interface Unit	3M Company	LMD	Class I	1992-05-27
K920194	Ultra-Vision Fast Detail Intensifying Screen	E.I. Dupont de Nemours & Co., Inc.	EAM	Class I	1992-05-27
K915154	Gambro Engstrom Y Filter Pkg. Alone W/ Var.models	C.G.H. Medical, Inc.	CAN	Class I	1992-05-27
K914965	Disposable Stylette with End Cap	Pivic Promedco	BSR	Class I	1992-05-27
K922107	Taylor Made Mobile Stander	Nelson A. Taylor Co., Inc.	IPL	Class II	1992-05-26
K922092	Single Chair Integral Back Attachment	Biodan Medical Systems, Ltd.	IKK	Class II	1992-05-26
K922061	Chair, Adjustable, Mechanical	Kaye Products, Inc.	INN	Class I	1992-05-26
K922045	Shower Chairs	Medical Device Inspection Company	INM	Class I	1992-05-26
K921998	Abuscreen(r) Online(tm) for Amphetamines, Modified	Roche Diagnostic Systems, Inc.	DKZ	Class II	1992-05-26
K921917	Dolomite Rollator	Seamark Technologies	INM	Class I	1992-05-26
K921903	Thyroxine Calibrator Kit	Tudor Laboratories, Inc.	JIS	Class II	1992-05-26
K921894	Rifton Mobile Prone Standers	Rifton Equipment for the Handicapped	IPL	Class II	1992-05-26
K921677	Biotrol Magnesium (Magon)	Biotrol, USA, Inc.	JGJ	Class I	1992-05-26
K921606	Model #125 Child Stimulation Pads	Cardiotronics, Inc.	LDD	Class II	1992-05-26
K921579	Br-50-J Disposable ECG Electrode	Medicotest, Inc.	DRX	Class II	1992-05-26
K921534	Dsl Dhea (Dsl 8900)	Diagnostic Systems Laboratories, Inc.	JKL	Class I	1992-05-26
K921445	Degubond Plus	Degussa AG	EJS	Class II	1992-05-26
K921419	Deva Plus	Degussa AG	EJS	Class II	1992-05-26
K921340	Force Measuring Platform	Sra Intl., Inc.	KHX	Class I	1992-05-26
K921073	Avi Model 480Ci Infusion Pump	3M Company	FRN	Class II	1992-05-26
K921072	Avi Model 470Ci Infusion Pump	3M Company	FRN	Class II	1992-05-26
K921070	Fortress 760-N 4 Wheel Power Wheelchair	Fortress Scientific, Ltd.	ITI	Class II	1992-05-26
K920868	Acetabular Dome and Screw Hole Plugs	Osteonics Corp.	JDL	Class III	1992-05-26
K920332	Heart Nubulizer	Vortran Medical Technology 1, Inc	CAF	Class II	1992-05-26
K921847	Action Fx Manual Wheelchair	Invacare GmbH	IOR	Class I	1992-05-22
K921463	Philips 31 Series in the Ear Hearing Aid	Philips Hearing Instruments Co.	ESD	Class I	1992-05-22
K921124	Models 6917T, 6917At & 4951M Epicardial Pace Leads	Medtronic, Inc.	DTB	Class III	1992-05-22
K921075	Phadebact Monoclonal Gc Test, Modification	Karo Bio Diagnostics AB	LIC	Class II	1992-05-22
K921037	Apolipoprotein Test System	Baxter Diagnostics, Inc.	MSJ	Class I	1992-05-22
K920972	Bactidrop Pyr	Remel Inc	JTO	Class I	1992-05-22
K920971	Bactidrop Ninhydrin	Remel Inc	JTO	Class I	1992-05-22
K920837	Sterile Convertor Safecare Gown and Drape	Baxter Healthcare Corporation	FYA	Class II	1992-05-22
K920835	Presaturation	Resonex, Inc.	LNH	Class II	1992-05-22
K920833	Rich-Mar Hv 1000 Muscle Stimulator	Rich-Mar Corp.	IPF	Class II	1992-05-22
K920805	Life Lite Emergency Stretcher	Design Principles, Inc.	FPP	Class I	1992-05-22
K920283	Disposable Skin Staple Remover	Trinity Laboratories, Inc.	MCZ	Class I	1992-05-22
K920225	Autosceptor Identification System	BD Becton Dickinson Vacutainer Systems Preanalytic	LRH	Class I	1992-05-22
K920119	3M Dental Electronic Anesthesia System	3M Company	LWM	Unclassified	1992-05-22
K914454	The Theratest El-Ana Profiles	Theratest Laboratories, Inc.	LKJ	Class II	1992-05-22
K913396	Cannula Style Thermocouples	Pro-Tech, Inc.	BZG	Class II	1992-05-22
K921550	Lifestream Centrifugal Pump System Model 2100Cp	Abbott Medical	KFM	Class II	1992-05-21
K920821	Unimax Model 2000 Color-Corrected Microspot CO2	Reliant Laser Corp.	GEX	Class II	1992-05-21
K920690	Norotrack 360 Inclinometer	Noromed, Inc.	KQX	Class I	1992-05-20
K920567	Models 3987 and 3988 Resume Lead for Pns	Medtronic, Inc.	GZF	Class II	1992-05-20
K920436	Medtronic Respond III Neuromuscular Stimulator	Medtronic, Inc.	IPF	Class II	1992-05-20
K920091	Iowa Oral Performance Isntrument	Breakthrough, Inc.	IKE	Class I	1992-05-20