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 2026-10-29, 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 851 of 3530

510(k) clearances, page 851 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K123529	Artis Q and Q.zen- Modular Angiographic System	Siemens Medical Solutions USA, Inc.	OWB	Class II	2013-02-26
K123433	Cedars-Sinai Cardiac Suite Nuclear Medicine Software	Cedars Sinai Medical Center	KPS	Class II	2013-02-26
K123316	Heine Omega 500	Heine Optotechnik GmbH & Co. KG.	HLI	Class II	2013-02-26
K122502	Bridge Extracellular Collegen Matrix	Harbor MedTech, Inc.	KGN	Unclassified	2013-02-26
K120817	Quanta Flash Acl Lga, Quanta Flash B2gp1 Iga	Inova Diagnostics, Inc.	MID	Class II	2013-02-26
K123656	Vertex Reconstruction System, Vertex Select Reconstruction System	Medtronic Sofamor Danek USA Inc	KWP	Class II	2013-02-25
K123549	Polaris Spinal System - Ballista II Percutaneous Screw Placement System	Biomet Spine (Aka Ebi, LLC)	NKB	Class II	2013-02-25
K123548	The Artas System	Venus Concept Inc.	ONA	Class II	2013-02-25
K123238	Achilles	GE Medical Systems China Co., Ltd.	MUA	Class II	2013-02-25
K122578	Vitrea CT Transcatheter Aortic Valve Replacment (Tavr) Planning	Canon Medical Informatics, Inc.	LLZ	Class II	2013-02-25
K130143	Persona Natural Tibia Baseplates	Zimmer GmbH	JWH	Class II	2013-02-22
K130058	Endoscopic Ultrasound Center EU-Y0008	Olympus Medical Systems Corp.	IYN	Class II	2013-02-22
K124061	MRI Patient Monitoring System (Model 865214)	Invivo Corporation	MWI	Class II	2013-02-22
K123809	Cd Horizon Spinal System	Medtronic Sofamor Danek USA Inc	NKB	Class II	2013-02-22
K123740	Eos	EOS imaging	MQB	Class II	2013-02-22
K123681	1.5T 4Ch Large Flex Coil, 1.5 4Ch Small Flex Coil	Wipro GE Healthcare Private Ltd.	MOS	Class II	2013-02-22
K123646	Emory Cardiac Toolbox 4.0	Syntermed, Inc.	KPS	Class II	2013-02-22
K123615	Iris - High Strength Glass Ceramic	Dentsply Intl.	EIH	Class II	2013-02-22
K123459	Zimmer Persona Tm Personalized Knee System	Zimmer GmbH	MBH	Class II	2013-02-22
K123187	Retrograde Coronary Sinus Cardioplegia Catheter, Retrograde Cardioplegia Catheter, Retrograde Cardioplegia Cannula	Edwards Lifesciences LLC	DWF	Class II	2013-02-22
K122727	Blue Sterile Powder Free Nitrile Examination Glove	Northstar Healthcare Holdings	LZA	Class I	2013-02-22
K122720	Lifestyles Warm Lovin Personal Lubricant	Ansell Healthcare Products LLC	NUC	Class II	2013-02-22
K122640	Vpulse	Cothera, LLC	JOW	Class II	2013-02-22
K122361	T:connect Data Management System	Tandem Diabetes Care, Inc.	OUG	Class I	2013-02-22
K122286	Mammomal Inspiration	Siemens Medical Solutions USA, Inc.	MUE	Class II	2013-02-22
K122185	U-Motion II Acetabular System	United Orthopedic Corp.	LZO	Class II	2013-02-22
K122015	Distal Femoral Growing Prosthesis, Tibial Rotating Components, Bearing, Axis, Circlip, Wedge	Howmedica Osteonics Corp	KRO	Class II	2013-02-22
K121795	Calcium Hydroxylapatite Vocal Fold Implant	Cytophil, Inc	MIX	Class II	2013-02-22
K121738	Myvisiontrack(tm)	Vital Art and Science Incorporated	HOQ	Class I	2013-02-22
K121435	Silkn Blue	Home Skinovations, Ltd.	OLP	Class II	2013-02-22
K121406	Inclusive Tapered Implant System	Prismatik Dentalcraft, Inc.	DZE	Class II	2013-02-22
K121374	Zi Blower	Deshum Medical	BZD	Class II	2013-02-22
K121043	Optos Oct/slo Microperimeter	Optos PLC.	OBO	Class II	2013-02-22
K130038	Powder-Free Nitrile Examination Gloves, Blue	HL Rubber Industries Sdn Bhd	LZA	Class I	2013-02-21
K124060	Medical Gorithmics Unified Arrhythmia Diagnostic System	Medicalgorithmics S.A.	DSI	Class II	2013-02-21
K124002	Verification Console	Varian Medical Systems, Inc.	LHN	Class II	2013-02-21
K123994	Dailies Aquacomfort Plus, Dailies Aquacomfort Plus Toric, Dailies Aquacomfort Plus Multifocal	Alcon Laboratories	LPL	Class II	2013-02-21
K123974	Percutaneous Introducer Kit	Teleflex Medical	DYB	Class II	2013-02-21
K123824	Vitro Fil Lc	DFL Industria e Comercio SA	EMA	Class II	2013-02-21
K123680	Coprancolor	White Peaks Dental Systems GmbH & Co. KG	EIH	Class II	2013-02-21
K123651	Cinchlock Knotless Suture Anchor	Pivot Medical	MBI	Class II	2013-02-21
K123638	Pekkton Ivory	Cendres & Metaux SA	EBG	Class II	2013-02-21
K123337	Vertessa Lite 10 X 20Cm, Vertessa Lite 11 X 30Cm	Caldera Medical, Inc.	OTO	Class II	2013-02-21
K123175	Detachatip III Plus Instrument Tray Model 3-4343	ConMed Corporation	KCT	Class II	2013-02-21
K122967	Lucent	Spinal Elements, Inc	MAX	Class II	2013-02-21
K122516	Embletta Mpr	Embla Systems	MNR	Class II	2013-02-21
K121735	Fiber Disk and Block Permanent, Trinia	Bioloren SRL	EBF	Class II	2013-02-21
K120861	Fin-S Microimplant	Creekside Orthodontics	OAT	Class II	2013-02-21
K113549	Comfort Cough	Seoil Pacific Corp	NHJ	Class II	2013-02-21
K123650	Arix Rad Acquisition Console	Compania Mexicana de Radiologia CGR, S.A. de C.V.	LLZ	Class II	2013-02-20