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 692 of 3530

510(k) clearances, page 692 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K151144	SuPro 100	3M Deutschland GmbH	EBG	Class II	2015-09-14
K143644	Premium Surgiclip¿; Endo Clip¿; AcuClip¿	Medtronic, Inc.	FZP	Class II	2015-09-14
K143177	KleenGel Dispenser	Kleengel, LLC	KYX	Class I	2015-09-14
K142657	Xerostom Saliva Substitute Gel	Bio Cosmetics S.L.	LFD	Unclassified	2015-09-14
K152303	CT Sim Laser System	Gammex, Inc.	IWE	Class I	2015-09-11
K152018	Varian Cleaning Caps, Varian Leak Stop Buttons, Varian Leak Stop Channel Marker Sets	Varian Medical Systems, Inc.	JAQ	Class II	2015-09-11
K151990	Tissue Removal System	Boehringer Laboratories, LLC	GCJ	Class II	2015-09-11
K151604	23ga Chandelier Illuminator, 25ga Chandelier Illuminator	Peregrine Surgical, LLC.	MPA	Class II	2015-09-11
K151560	QuickPlan	Siris Medical	MUJ	Class II	2015-09-11
K151368	Spectra Optia Apheresis System, Spectra Optia Exchange Set (with AC Connection), Spectra Optia AC Connection Adapter	Terumo BCT, Ltd	LKN	Unclassified	2015-09-11
K151324	Straumann Variobase for CEREC	Straumann USA, LLC	NHA	Class II	2015-09-11
K150619	CONSTRUX Mini PEEK Spacer System, CONSTRUX Mini PEEK Ti Spacer System	Orthofix SRL	ODP	Class II	2015-09-11
K150381	Aqua Cleanse	Quality Medical Supply, Inc.	KPL	Class II	2015-09-11
K143413	J+PRAS YOUNG'S Thread	Y. Jacobs Medical, Inc.	NEW	Class II	2015-09-11
K143359	CG-6108 ACT-3L Continuous ECG Monitor and Arrhythmia Detector	Lifewatch Technologies, Ltd.	DSI	Class II	2015-09-11
K152302	Xenco Medical Cervical Interbody System (Argus)	Xenco Medical LLC	ODP	Class II	2015-09-10
K152279	ViZion DR + Wireless	Viztek, LLC	MQB	Class II	2015-09-10
K151982	Stat Profile Prime ABG Analyzer System	Nova Biomedical Corporation	CHL	Class II	2015-09-10
K151972	JUSHA-C43 LCD Monitor	Nanjing Jusha Display Technology Co., Ltd	PGY	Class II	2015-09-10
K151944	Luggie Super	Freerider, Corp.	INI	Class II	2015-09-10
K151861	JUSHA-C23C LCD Monitor	Nanjing Jusha Display Technology Co., Ltd	PGY	Class II	2015-09-10
K151795	ML24000 UVA-1 Phototherapy Cabinet	The Daavlin Distributing Co.	FTC	Class II	2015-09-10
K151695	Romeo posterior osteosynthesis system	Spineart SA	MNH	Class II	2015-09-10
K151649	Valleylab FT10 Electrosurgical Platform	Medtronic, Inc.	GEI	Class II	2015-09-10
K151526	Zone, ZoneFree, Zone A1	Sybron Dental Specialties, Inc.	EMA	Class II	2015-09-10
K151472	NuVasive CoRoent Lumbar System	Nu Vasive, Incorporated	MAX	Class II	2015-09-10
K151394	Keeler Slit Lamp	Keeler Ltd.	HJO	Class II	2015-09-10
K151339	SONON Ultrasound Imaging System (Model: SONON 300C)	Healcerion Co., Ltd	IYO	Class II	2015-09-10
K151322	Amendia Interbody Fusion Devices	Spinal Elements, Inc	MAX	Class II	2015-09-10
K151112	Quill Polypropylene Knotless Tissue-Closure Device, Variable Loop Design	Angiotech	GAW	Class II	2015-09-10
K150959	Sutter Bipolar Forceps-Calvian	Sutter Medizintechnik GmbH	GEI	Class II	2015-09-10
K150840	Ligaclip 10mm M/L Endoscopic Rotating Multiple Clip Applier	Ethicon Endo-Surgery Inc	FZP	Class II	2015-09-10
K150112	Hs Amica Devices Family	H.S. Hospital Service S.p.A.	GEI	Class II	2015-09-10
K152269	Healgen Amphetamine Test (Strip, Cassette, Cup, Dip Card), Healgen Cocaine Test (Strip, Cassette, Cup, Dip Card), Healgen Methamphetamine Test (Strip, Cassette, Cup, Dip Card)	Healgen Scientific LLC	DKZ	Class II	2015-09-09
K152268	VAPRO PLUS POCKET Intermittent Catheter	Hollister Incorporated	GBM	Class II	2015-09-09
K151968	Cryocare CS-3 Surgical System version 5	Varian Medical Systems, Inc.	GEH	Class II	2015-09-09
K151601	Secure-Loop	Xiros Ltd	MBI	Class II	2015-09-09
K150576	TGM Biolox delta Ceramic Heads	Tgm Medical, Inc.	LZO	Class II	2015-09-09
K143637	U&U Sterilization Pouch and Roll	U&u Medical Technology Co., Ltd	FRG	Class II	2015-09-09
K143507	NFANT Feeding Solution	NFANT LABS Inc	HCC	Class II	2015-09-09
K142821	PAXgene Blood DNA Tube	Preanalytix GmbH	PJE	Class II	2015-09-09
K152286	LigaSure Curved, Small Jaw, Open Sealer/Divider	Medtronic, Inc.	GEI	Class II	2015-09-08
K151668	S-scan	Esaote S.p.A.	LNH	Class II	2015-09-08
K151460	Fully Automatic Electronic Blood Pressure Monitor	Andon Health Co., Ltd	DXN	Class II	2015-09-08
K141488	Careview 1800R	Careray Digital Medical System Co., Ltd.	MQB	Class II	2015-09-08
K151595	On Call Express Pro Blood Glucose Monitoring System	Acon Laboratories, Inc.	NBW	Class II	2015-09-05
K152176	Immunalysis PCP Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators	Immunalysis Corporation	LCM	Unclassified	2015-09-04
K152015	Pyrenees Cervical Plate System	K2M, Inc	KWQ	Class II	2015-09-04
K151838	PRO-TOE Hammertoe Fixation System	Wrightmedicaltechnologyinc	HWC	Class II	2015-09-04
K151822	ab medica irrigation/suction gravity system	AB Medica SAS	GCJ	Class II	2015-09-04