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 882 of 3530

510(k) clearances, page 882 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K120921	Clever Choice	Simple Diagnostics	CGA	Class II	2012-08-21
K113568	Mta-Fillapex	Paxmed International, LLC	KIF	Class II	2012-08-21
K113312	Hy-Chlo(tm)wound Scrub	Patrin Pharma	FQH	Class II	2012-08-21
K113062	Endoservice Endoscopic Instruments & Accessories and Minimally Invasive Gi and Gu Devices	Endoservice Optical Instruments GmbH	FBP	Class II	2012-08-21
K112916	Tysonbio Md100 Blood Glucse Monitoring ,Tysonbio Md100 Pro Blood Glucise Monitoring System	Tyson Bioresearch, Inc.	NBW	Class II	2012-08-21
K111914	Virtual Slide System, Olympus Vs800 System	Olympus America Inc. / Scientific Equipment Group	OEO	Class II	2012-08-21
K111627	Supera Veritas(r) Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System	Idev Technologies, Inc.	FGE	Class II	2012-08-21
K122179	Vasopress Dvt Leg Garments (Sterile) Vasopress Dvt Foot Garments (Sterile)	Compression Therapy Concepts, Inc.	JOW	Class II	2012-08-20
K121720	Welkins Emt/icu Temperature Managerment System	Welkins, LLC	DWJ	Class II	2012-08-20
K121452	Gridlock Plating System	Trilliant Surgical LLC	HRS	Class II	2012-08-20
K121154	Ultrasonic Nebulizer	Foshan Gaunying Electronics Co., Ltd	CAF	Class II	2012-08-20
K121148	Samba Screw, 9Mm Dia., 25Mm Long, Sambia Screw, 9Mm Dia., 30Mm Long, Samba Screw 9Mm Dia., 35Mm Long, Samba Screw, 9Mm D	Medical Design, LLC	HWC	Class II	2012-08-20
K120835	Dynatron Thermostim Probe-Done	Dynatronics Corp.	GXY	Class II	2012-08-20
K120500	The Pain Pilot (A.k.a Pain Pilot)	Hollywog, LLC	NUH	Class II	2012-08-20
K120486	Avs as Peek Spacer	Howmedica Osteonics Corp	ODP	Class II	2012-08-20
K111460	Opto Hyalus Green Laser	Opto Eletronica S/A	HQF	Class II	2012-08-20
K122203	Truetome	Boston Scientific Corporation	KNS	Class II	2012-08-17
K122190	Prelude 7F Short Sheath Introducer	Merit Medical Systems, Inc.	DYB	Class II	2012-08-17
K122145	Lanx Spinal Fixation System	Lanx, Inc.	NKB	Class II	2012-08-17
K122138	Atrium Flixene Ifg Vascular Graft	Atrium Medical Corporation	DSY	Class II	2012-08-17
K121911	Octave Speeder Spine	Toshiba Medical Systems Corporation, Japan	MOS	Class II	2012-08-17
K121910	Octave Speeder Head	Toshiba Medical Systems Corporation, Japan	MOS	Class II	2012-08-17
K121718	A-V Foot Pump	Dalian Labtek Science & Development Co Ltd	JOW	Class II	2012-08-17
K121497	Venofer Pump	Renal Solutions, Inc.	KDI	Class II	2012-08-17
K121176	Stgc	Cardinal Spine, LLC	MQP	Class II	2012-08-17
K121062	Vivid I Diagnostic Ultrasound System, Vivid Q Diagnostic Ultrasound System	GE Medical System Israel, Ltd.	ITX	Class II	2012-08-17
K121025	Ya Horng Blood Pressure Monitor, Ya Horng Blood Pressure Monitor, Bluetooth Transmission	Ya Horng Electronic Co., Ltd.	DXN	Class II	2012-08-17
K120890	Powder-Free Nitrie Examination Gloves, Orange	Shen Wei (USA), Inc.	LZA	Class I	2012-08-17
K120151	Nebulae I	Northgate Technologies Inc.	HIF	Class II	2012-08-17
K120030	Taperloc Complete Size 4Mm and Xr 123	Biomet Manufacturing Corp	LPH	Class II	2012-08-17
K120008	Medline High Pressure Injection Tubing	MEDLINE INDUSTRIES, LP - Northfield	DQO	Class II	2012-08-17
K113809	Hitachi Clinical Analyzer S Test Regent Cartridge C-Reactive Protein (Crp)	Canon Medical Diagnostics USA, Inc.	DCN	Class II	2012-08-17
K113715	Lung Volume Analysis	Toshibamedical Systems Corporation	JAK	Class II	2012-08-17
K113128	Microaire Surgical Instruments Llc	MicroAire Surgical Instruments, LLC	QPB	Class II	2012-08-17
K112373	Calaview Color (Etafilcon a) Soft (Hydrophilic) Contact Lens for Daily Wear Modification	Innova Vision Inc.	LPL	Class II	2012-08-17
K122329	Biojet	Jet Soft SRL	LLZ	Class II	2012-08-16
K122234	Oec 9900 Elite	GE Healthcare Surgery GE Oec Medical Systems, Inc.	OWB	Class II	2012-08-16
K122182	Digital Flat Panel X-Ray Detector/1717sgc	Rayence Co., Ltd.	MQB	Class II	2012-08-16
K121863	Vitek 2 Ast-St Cefotaxime	bioMerieux, Inc.	LON	Class II	2012-08-16
K121855	Resprocessed Serfas Energy Probe	Stryker Sustainability Solutions	NUJ	Class II	2012-08-16
K121548	Spinevu Endoscopic Spine System (Sess)	Spine View, Inc.	HRX	Class II	2012-08-16
K121422	Aplio 500/400/300 Diagnostic Ultrasound System	Toshiba Medical Systems Coporation, Japan	IYO	Class II	2012-08-16
K121173	Chord-X Eptfe Suture	On-Xlifetechnologies	PAW	Class II	2012-08-16
K121095	Dx-D Imaging Package	AGFA Healthcare Corp.	MQB	Class II	2012-08-16
K120986	Stratify Jcv Dxselect	DiaSorin Molecular LLC	OYP	Class II	2012-08-16
K120398	Witouch Pro	Hollywog, LLC	GZJ	Class II	2012-08-16
K122205	Exini	Exini Diagnostics AB	LLZ	Class II	2012-08-15
K122070	Chocolate Pta Balloon Catheter (Over the Wire) 0.014 Guide Wire, Chocolate Pta Balloon Catheter (Over the Wire) 0.18 G	Trireme Medical, Inc.	LIT	Class II	2012-08-15
K122036	Visi Mobile Monitoring System	Sotera Wireless	MWI	Class II	2012-08-15
K121727	Movation Knee System	Encore Medical, LP	OIY	Class II	2012-08-15