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 2026-10-26, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,069 of the 176,466 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	2,669

176,466 records, page 2792 of 3530

510(k) clearances, page 2792 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K872608	Hewson A.c.l. Guide Set	Concept, Inc.	KGS	Class I	1987-09-16
K872486	Larkel Device W/attachments a-H	Seidel Medizin GmbH	BTO	Class II	1987-09-16
K872353	Surgitek Infusion Stent System*	Surgitek	FAD	Class II	1987-09-16
K872093	Rvt-50 Rotary Chair for Vestibular Testing	Ics Medical Corp.	LXV	Unclassified	1987-09-16
K872041	Coulter Dart Ck-Mb Isoenzyme Reagent System	Coulter Electronics, Inc.	JHT	Class II	1987-09-16
K871632	Nasogastric Voicetube	American Omni Medical, Inc.	BTR	Class II	1987-09-16
K871586	Glucochek S.c. with Audio Option	Larken Industries, Inc.	CGA	Class II	1987-09-16
K871573	Central Venous Multi-Lumen Catheters and Kits	Spectramed, LLC	DQY	Class II	1987-09-16
K863920	Wako(tm) Zn Test	FUJIFILM Healthcare Americas Corporation			1987-09-16
K873071	Bunn Concentrator Model 2100 Series	The John Bunn Co.	CAW	Class II	1987-09-15
K873070	Hearing Aid (in-the-Ear)	Central Illinois Hearing Aid Centers, Inc.	ESD	Class I	1987-09-15
K873069	Modified Visio-Seal	Espe GmbH (US)	EBC	Class II	1987-09-15
K873004	Guiding Catheter	Mallinckrodt Critical Care	DQO	Class II	1987-09-15
K872932	Moss(r) Mark IV Nasal Tubes Cat.# 87168	Mfg. and Research, Inc.	KNT	Class II	1987-09-15
K872925	Megabed 1000	Surgi-Med, Inc.	FNL	Class II	1987-09-15
K872898	Polyurethane Catheter for the Infuse-a-Port	Shiley Infusaid, Inc.	LJT	Class II	1987-09-15
K872790	Perfusion Catheter	BD Becton Dickinson Vacutainer Systems Preanalytic	DQT	Class II	1987-09-15
K872731	Picf 0860/Pscf 0860/Psc 0860/Piaf 0860/Psaf 0860	Ela Medical, Inc.	DTB	Class III	1987-09-15
K872724	Sheath/dilators	Med-West, Inc.	DRE	Class II	1987-09-15
K872629	Takeda Medical Digital Sphygmomanometer/ Ua-741	A and D Engineering, Inc.	DXN	Class II	1987-09-15
K872626	Oximetry Module	Marquette Electronics, Inc.	DQA	Class II	1987-09-15
K872621	Trach Care Catheter	Ballard Medical Products	BSY	Class I	1987-09-15
K872529	Thermodilution Cardiac Output Computer, Mod. Com-2	American Edwards Laboratories	DXG	Class II	1987-09-15
K872456	Hemocor Plus Hemoconcentrator	Medivators Inc	KDI	Class II	1987-09-15
K872355	Colin's Model Apbm-630 and Quinton's Model 470	Colin Medical Instruments Corp.	DXN	Class II	1987-09-15
K872230	Model 366-29 Adaptaid(tm) Adapter Sleeve	Intermedics, Inc.	DBT	Class I	1987-09-15
K872139	Mr420 Transport Humidifier	Fisher & Paykel Allied Products, Ltd.	BTT	Class II	1987-09-15
K871882	Lake Region Variable Stiffness Guidewire (Vsgw)	Lake Region Mfg., Inc.	DQX	Class II	1987-09-15
K871693	Sleep Apnea Nasal CPAP System	Medtronic, Inc.	BYE	Class II	1987-09-15
K871271	Huntleigh Flowpress Ac300 Pump, Sq301/302/320 Gar.	Huntleigh Technology, Inc.	DRM	Class II	1987-09-15
K873455	S3086 Arterial, S3087 Venous Neonatal Hemodialysis	Dravon Medical, Inc.	FJK	Class II	1987-09-14
K873424	Easy-Test Conjugated Bilirubin (Cbil) #16690	Em Diagnostic Systems, Inc.	CIG	Class II	1987-09-14
K873397	Dahlberg Model Mh Behind-the-Ear Hearing Aid	Dahlberg Electronics, Inc.	ESD	Class I	1987-09-14
K873376	Model Si and Sp Behind-the-Ear Hearing Aid	Dahlberg Electronics, Inc.	ESD	Class I	1987-09-14
K873138	Micro-Reader II	Hyperion, Inc.	JJQ	Class I	1987-09-14
K873052	Stratus(r) Hlh Fluorometric Enzyme Immunoassay	American Dade	CEP	Class I	1987-09-14
K873033	Hcg Serozyme Immunoenzym Assay Kit/mag Solid Phase	Serono Diagnostics, Inc.	JHI	Class II	1987-09-14
K872916	Histomatic Slide Stainer, Code-on Version	Fisher Scientific Company L.L.C.	KPA	Class I	1987-09-14
K872760	Oscar(tm) Pb255 Oximeter Capnometer	Datex Division Instrumentarium Corp.	CCK	Class II	1987-09-14
K872690	Iafp V. Agar Selective	I.A.F. Production, Inc.	JSJ	Class I	1987-09-14
K872646	Viron(tm)	bioMerieux, Inc.	JJT	Class I	1987-09-14
K872568	Rotascreen	Mercia Diagnostics, Ltd.	GOB	Class I	1987-09-14
K872542	Schneider-Shiley Softrac-Pta(tm) Angio. Catheter	Angiomedics, Inc.	LIT	Class II	1987-09-14
K872472	Schneider-Shiley Biflator Balloon Inflation Device	Angiomedics, Inc.	DXT	Class II	1987-09-14
K872392	Aca Urine Drugs of Abuse Calibrator	E.I. Dupont de Nemours & Co., Inc.	DKB	Class II	1987-09-14
K872378	William Harvey Hardshell Venous Reservoir	C.R. Bard Inc	DTN	Class II	1987-09-14
K872282	Flexible Ureteroscope	Intramed Laboratories, Inc.	FGB	Class II	1987-09-14
K871492	Ais Angioscope	Advanced Interventional Systems, Inc.	DQX	Class II	1987-09-14
K870924	Clx Acetabular Cup (Wagner) for Cementless Fixat.	Protek, Inc.	KWA	Class III	1987-09-14
K870923	Schuster Acetabular Cup for Cement/cementless Fix.	Protek, Inc.	KWA	Class III	1987-09-14