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 2026-10-12, 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 3271 of 3528

510(k) clearances, page 3271 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K812460	Various Aural Grommets	Exmoor Plastics Limited	ETD	Class II	1981-09-21
K812457	Hiflo-Hp	Tri-Med, Inc.	FPB	Class II	1981-09-21
K812450	Koi Diamond Knife	Koi, Inc.	HNN	Class I	1981-09-21
K812433	Lensine Extra Strength Cleaner	CooperVision, Inc.	HPX	Unclassified	1981-09-21
K812419	Preset Flowmeter	Timeter Instrument Corp.	CAX	Class I	1981-09-21
K812360	Precious-Metal/plastic Attach., Auxill	Zl-Microdent-Attachments	EGG	Class I	1981-09-21
K812342	Zee Extrication Device	Zee Medical Products Co., Inc.	IQF	Class I	1981-09-21
K812325	Intk-08 8 French Introducer Kit W/side	Sorensen Research	DYB	Class II	1981-09-21
K812317	Defibrillator/monitor	Hewlett-Packard Co.	LDD	Class II	1981-09-21
K812307	Usci Transthoracic Temp. Pacing Electrod	C.R. Bard Inc	LDF	Class II	1981-09-21
K812300	Lingual Bracket	American Ormco	EJF	Class I	1981-09-21
K812259	Nivp Monitor	Datascope Corp.	DXN	Class II	1981-09-21
K812239	Unitek Palatal Bar	Unitek Corp.	DYT	Class I	1981-09-21
K812175	Endocervical Aspirator	Fertility Instrumentation, Inc.	HFC	Class II	1981-09-21
K812163	Aire-Cuf Tracheostomy Tube	Bioana Surgical Instruments, Inc.	JOH	Class II	1981-09-21
K812131	Portapulse	Gavon, Inc.	DRT	Class II	1981-09-21
K812040	Oxygen Monitor 140/141	Medix Medical Electronics (U.S.A.), Inc.	CCL	Class II	1981-09-21
K811995	Foramatron Apical Foramen Locator	Parker Laboratories, Inc.			1981-09-21
K811863	Steri-Tract	Rogo Ent.	KDJ	Class II	1981-09-21
K811830	C-Dak Duo-Flux Artificial Kidney	Cordis US Corp.	KDI	Class II	1981-09-21
K811761	The Emmett IUD Thread Retriever	Proto-Med, Inc.	HHF	Class I	1981-09-21
K810913	Cavity Varnish	Dentsply Intl.	LBH	Class II	1981-09-21
K810876	Spectacle Frames	Fashionline Corp.	HQZ	Class I	1981-09-21
K812126	Ultrasonic Tips	CooperVision, Inc.	HQC	Class II	1981-09-18
K811718	Surface Replacement Hip Prosthesis	Zimmer GmbH	KYB	Class I	1981-09-18
K801550	3M Germicidal Surgical Incise Drape	3M Company	KKX	Class II	1981-09-17
K812527	Iva Seal II	U.S. Clinical Products, Inc.	KPE	Class II	1981-09-16
K812526	Micro Blade II	Vxtra Corp.	GES	Class I	1981-09-16
K812510	Travenol Infusion Controller 2M8052	Travenol Laboratories, S.A.	LDR	Class II	1981-09-16
K812505	Pall Ultipor Vacuum Line Bacteria Fitler	Pall Biomedical Products Co.	JQC	Class I	1981-09-16
K812499	Infusion Pump	Nu Tech Medical Systems	FRN	Class II	1981-09-16
K812442	3M Infusion System	3M Company	FRN	Class II	1981-09-16
K812418	Medtronic #3798 Electrode	Medtronic, Inc.	GXY	Class II	1981-09-16
K812353	Kf-E Series of Hollow Fiber Dialyzers	Medisystems Corp.	FJI	Class II	1981-09-16
K812332	Kermath L/c Arm	Kermath Mfg. Corp.	KPR	Class II	1981-09-16
K812311	Circulating Cyto-Therms	Cryosan, Inc.	KZL	Class II	1981-09-16
K812309	Cryosan Normal Saline	Cryosan, Inc.	GIF	Class I	1981-09-16
K812270	Perm. Endocardial Unipolar Tined Atrial	Diag Corp.	DTB	Class III	1981-09-16
K812217	Fluoro Automatic Brightness Sys	Keystone X-Ray, Inc.	JAA	Class II	1981-09-16
K812158	Lkb-Bromma 2188 Ultrotome Nova	Lkb Instruments, Inc.	IDM	Class I	1981-09-16
K812096	Medtronic Enertrax Model 7100	Medtronic, Inc.	DXY	Class III	1981-09-16
K812014	Dynex-44 Diagnostic Ultrasound Imaging	Elscint, Inc.	IYO	Class II	1981-09-16
K811974	Microcoil 150 Dialyzer	Erika, Inc.	FHS	Class II	1981-09-16
K811841	Gore-Tex Cardiovascular Patch	W. L. Gore & Associates, Inc.	DXZ	Class II	1981-09-16
K811671	Cytomegalovirus Antibody Test System	Zeus Scientific LLC	GQH	Class II	1981-09-16
K811567	Ortho* Bi-Level Assayed Glycoh. Contr. S	Ortho Diagnostic Systems, Inc.	LCP	Class II	1981-09-16
K811441	Manufacturing Process Change	Meadox Medicals, Div. Boston Scientific Corp.	DSY	Class II	1981-09-16
K811425	Cardiacmonitors	Pulse Time Products, Ltd.	DRT	Class II	1981-09-16
K810958	Glycohemoglobin	Macomb Chemical Co.	LCP	Class II	1981-09-16
K812507	The Keofeed Stomach Tube	Hedeco	KNT	Class II	1981-09-14