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 879 of 3530

510(k) clearances, page 879 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K122164	Mr Vessellq Xpress	GE Medical Systems SCS	LLZ	Class II	2012-09-07
K122136	Vitreaview	Canon Medical Informatics, Inc.	LLZ	Class II	2012-09-07
K121983	Diagnostic Doppler Ultrasound System Curved Linear Array 2-5 Mhz Transducer Linear Array 5-11 Mhz Transducer Phase Arra	Benq Medical Technology Corpation	IYN	Class II	2012-09-07
K121941	Arrow Picc Powered by Arrow Vps Stylet	Arrow International (Subsidiary of Teleflex Inc.)	LJS	Class II	2012-09-07
K121914	Masimo Set Uspo2 Pulse Oximetry Cable	Masimo Corporation	DQA	Class II	2012-09-07
K121797	Bd Veritor(tm) System for Rapid Detection of Flu A+b	Becton Dickinson & Co	PSZ	Class II	2012-09-07
K121749	Veracia	Shofu Dental Corp.	ELM	Class II	2012-09-07
K121714	Smith & Nephew, Inc. Shoulder System Instruments	Smith & Nephew, Inc.	HSD	Class II	2012-09-07
K121641	Miniarc Pro Single-Incision Sling System	American Medical Systems, Inc.	PAH	Class II	2012-09-07
K121366	Hemocue Hba1c 501	Infopia Co, Ltd.	LCP	Class II	2012-09-07
K121353	Mini Patch	Well-Life Healthcare Limited	NUH	Class II	2012-09-07
K121228	Ponto Bone Anchored Hearing System	Oticon Medical AB	MAH	Class II	2012-09-07
K120875	B&w Dental Implant System	B&W SRL	DZE	Class II	2012-09-07
K120685	Zyno Medical Administration Set	Zyno Medical LLC.	FPA	Class II	2012-09-07
K120609	Vitros Chemistry Products Dhdl Slides	Ortho-Clinical Diagnostics, Inc.	LBS	Class I	2012-09-07
K113821	Transonic Costatus Cardiac Output System	Transonic Systems Inc	DXG	Class II	2012-09-07
K113761	Infrared Thermometer	Famidoc Technology Co., Ltd	FLL	Class II	2012-09-07
K113407	Snowden Pencer Laparoscopic Ergonomic Reposable Scissors	Medtronic, Inc.	GEI	Class II	2012-09-07
K122628	Sensation Plus 7.5Fr. 40Cc Intra-Aortic Balloon (Iab) Catheter and Accessories	Datascope Corp., Cardiac Assist Division	DSP	Class II	2012-09-06
K122442	Depuy Cta Reverse Shoulder System	Depuy France	PHX	Class II	2012-09-06
K122397	Liaison Rubella Igm, Liaison Control Rubella Igm	Diasorin Inc.	LFX	Class II	2012-09-06
K122005	Maxlock Extreme System	TORNIER Inc.	HRS	Class II	2012-09-06
K121974	Conformis Iuni Unicondylar Knee Replacement System	ConforMIS, Inc.	HSX	Class II	2012-09-06
K121309	Asc Quadport + Laparoscopic Access Device	Advanced Surgical Concepts	OTJ	Class II	2012-09-06
K120814	Padlock Clip-12	Aponos Medical Corp.	PKL	Class II	2012-09-06
K120732	Lenssx Laser System	Alcon Lensx, Inc.	HQC	Class II	2012-09-06
K120730	Loutrex Topical Cream	Acella Pharmaceuticals, LLC	FRO	Unclassified	2012-09-06
K113648	Loqteq Large Fragment Set Loqteq Cortical Screw 4.5, Small Head, T25, Self Tapping Loqteq Cortical Screw 4.5, T25, Self	AAP Implantate AG	HRS	Class II	2012-09-06
K112892	Impella 2.5 Plus Catheter	Abiomed, Inc.	PBL		2012-09-06
K112200	Focus Touch Conception System	Intimate Bridge 2 Conception, Inc.	OBB	Class II	2012-09-06
K122583	Ugeo G60 Diagnostic Ultrasound System	Samsung Medison Co., Ltd.	IYN	Class II	2012-09-05
K122544	Terumo Surflash Safety i.v. Catheter	Terumo Corp.	FOZ	Class II	2012-09-05
K122379	Flash Pta Balloon Dilatation Catheter - 4Mm X 14Mm X 135Cm, Flash Pta Balloon Dilatation Catheter - 4Mm X 19Mm X 135Cm	Verge Medical Inc.	LIT	Class II	2012-09-05
K122216	Reliance Anterior Cervical Plate System	Reliance Medical Systems, LLC	KWQ	Class II	2012-09-05
K122030	Low Profile Gastrostomy Feeding Tube or Gastrotomey Button	Degania Silicone, Inc.	KNT	Class II	2012-09-05
K121893	Stryker Sdc3 Hd Information Management System	Stryker Corp.	GCJ	Class II	2012-09-05
K121787	Biohorizons Tapered Internal Plus Implants	BioHorizons Implant Systems Inc	DZE	Class II	2012-09-05
K121654	Auto-Chek Blood Glucose Monitoring System, Meter, Test Strip. Auto-Check Control Solution	I-SENS, Inc.	CGA	Class II	2012-09-05
K121415	Mollring Multitasc	LeMaitre Vascular Inc.	DWX	Class II	2012-09-05
K121383	Ps X Series (Basic Components and Catheter), Pd X Series (Catheter with All Components)	Medical Components, Inc.	FJS	Class II	2012-09-05
K120992	Mets Smiles Total Knee Replacement	Stanmore Implants Worldwide, Ltd.	KRO	Class II	2012-09-05
K120792	Tixos Implant System	Leader Italia S.r.l.	DZE	Class II	2012-09-05
K120064	Test, Blood Glucose System	HMD Biomedical, Inc.	NBW	Class II	2012-09-05
K113572	Ligasure Curved, Small Jaw, Open Sealer/divider	Covidien, Formerly Valleylab, A Division of Tyco H	GEI	Class II	2012-09-05
K113376	Neoss Proactive Tapered Implant	Neoss, Ltd.	DZE	Class II	2012-09-05
K122565	Arc Endocuff	Boddingtons Plastics, Ltd.	FED	Class II	2012-09-04
K122155	Pch-2500 Digital Extraoral Source X-Ray System Pax-I Digital Extraoral Source X-Ray System	Vatech Co., Ltd.	MUH	Class II	2012-09-04
K122047	Alamo P	Alliance Partners, LLC	MAX	Class II	2012-09-04
K122042	Cellvizio 100 Series and Cellvizio Systems with Confocal Miniprobes	Mauna Kea Technologies	OWN	Class II	2012-09-04
K121034	Ioi Total Hip	Iconacy Orthopedic Implants, LLC	LPH	Class II	2012-09-04