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 2026-11-02, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,132 of the 176,529 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	2,732

176,529 records, page 951 of 3531

510(k) clearances, page 951 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K101572	Immulite 2000 3Gallergy Specific Ige Assay Kit	Siemens Healthcare Diagnostics Inc.	DHB	Class II	2011-08-01
K111906	Xcela Hybrid Picc with Pasv Valve Technology	Boston Scientific Corporation	LJS	Class II	2011-07-29
K111884	Over-the-Wire Expandable Lemaitre Valvulotome	LeMaitre Vascular Inc.	MGZ	Class II	2011-07-29
K111870	Amsco Warming Cabinet	STERIS Corporation	LGZ	Class II	2011-07-29
K111611	Endomaxx Fully Covered Esophageal Stent	Merit Medical Systems, Inc.	ESW	Class II	2011-07-29
K111556	Glidecross Support Catheter	Terumo Medical Corp.	DQY	Class II	2011-07-29
K111529	Magnum Core Tissue Biopsy Needle Model Mn1820, Rp Cutting Needle Model Rp-1820, Mcn Core Tissue Biopsy Needle Model Mcn-	Insert Molding Solutions, Inc.	KNW	Class II	2011-07-29
K111424	Vacuette Premium Safety Needle System Tube-Touch	Medpro Safety Products, Inc.	FMI	Class II	2011-07-29
K111245	Heartnavigator Release 1	Philips Medical Systems Nederland B.V.	LLZ	Class II	2011-07-29
K110778	Biodenta Customized Abutment	Biodenta Swiss AG	NHA	Class II	2011-07-29
K110600	Collagen Dental Mambrane - Porcine Type I Collagen	Collagen Matrix, Inc	NPL	Class II	2011-07-29
K110548	Osi O-Ball Abutment Head Implants	Juell Dental	DZE	Class II	2011-07-29
K110390	Etg 255 Combo Stimualtor, Ten 260 Stimualtor	Handelshaus Dittman GmbH	GZJ	Class II	2011-07-29
K110376	Pe-210Ak Switch Box	Nihon Kohden Corp.	GWQ	Class II	2011-07-29
K103830	Jiangsu Shenli Medical Production Co. Ltd. Piston Syringe (5Cc Luer Lock)	Jiangsu Shenli Medical Production Factory	FMF	Class II	2011-07-29
K103740	Sodium Chloride Injection, 0.9%, Usp 5 Ml, 10 Ml Ampule	Spectra Medical Devices, LLC	NGT	Class II	2011-07-29
K103220	Voyager Peritoneal Dialysis System	Deka Research & Development Corp.	FKX	Class II	2011-07-29
K102051	Pain Buddy	BioMedical Life Systems Inc.	NUH	Class II	2011-07-29
K111892	Vitreaview Software 6.1	Canon Medical Informatics, Inc.	LLZ	Class II	2011-07-28
K111821	Biopsy Valve	Boston Scientific Corporation	OCX	Class II	2011-07-28
K111804	Intellispace Pacs 4.X	Philips North America LLC	LLZ	Class II	2011-07-28
K111400	Optetrak Logic Cr Tibial Insert, Optetrak Logic Cr Femoral Component	Exactech, Inc.	JWH	Class II	2011-07-28
K111393	Snap (R) Wound Care System	Spiracur, Inc.	OKO	Class II	2011-07-28
K111222	MRI-Q System	Resonance Health Analysis Services Pty Ltd	LLZ	Class II	2011-07-28
K111212	Smr Shoulder System- Revision Stems	Lima Corporate S.p.A.	KWS	Class II	2011-07-28
K111191	Audible Pressure Release Valve with Humidifier Adapter / and Oxygen Nipple	Wet Nose Technologies, LLC	CBP	Class II	2011-07-28
K111000	Parcus 2.0Mm / 2.5Mm / 3.5Mm Miti Titanium Suture Anchor	Parcus Medical, L.L.C.	HWC	Class II	2011-07-28
K110789	Synthes Sternal Zipfix System	Synthes (USA) Products LLC	JDQ	Class II	2011-07-28
K110723	M-Lncs Oximetry Sensors, Reprocessed M-Lncs Oximetry Sensors	Masimo Corporation	NLF	Class II	2011-07-28
K110631	Venner Tracheal Seal Monitor	Venner Medical (Singapore) Pte Ltd	BSK	Class II	2011-07-28
K110571	Telcare Blood Glucose Monitoring System, Test Strips, Control Solutions, Telserve-Home Use, Telserve-Professional Use	Telcare, LLC	NBW	Class II	2011-07-28
K110419	Avs Aria Neuromonitoring Probe and Avs Aria Probe Dilators	Howmedica Osteonics Corp	GXZ	Class II	2011-07-28
K110261	Eni-Eye Sh Toric (Efrofilcon a) Soft Hydrophilic Toric Contact Lens for Daily Wear, Multifocal Contact Lens, Keratoconus	Soflex Limited	LPL	Class II	2011-07-28
K103574	Pregnancy One Step Rapid Test	Lehnus & Associates Consulting	LCX	Class II	2011-07-28
K103130	Xelis 3D	Infinitt Co., Ltd.	LLZ	Class II	2011-07-28
K102528	N-Force Fixation System	Innovision, Inc.	HWC	Class II	2011-07-28
K111972	Affinity Cp Centrifugal Pump, Resting Heart Sys.,myotherm Cardioplegia Deliv.,affinity Hollow Fiber Oxygenator,aaf	Medtronic, Inc.	KFM	Class II	2011-07-27
K111752	Powder Free Vinyl Patient Examination Gloves, Clear (Non-Colored)	Shandong Jianhong New Material Company	LYZ	Class I	2011-07-27
K111517	Pharmajet Stratis 0.5 Ml Needle-Free Injection System Model 501-01, Stratis Injector Catalog 501-10, Stratis Reset Stati	Pharmajet, Inc.	KZE	Class II	2011-07-27
K111493	Nidek Multicolor Scan Laser Photocoagulator Mc-500 Vixi	Nidek Co., Ltd.	HQB	Class II	2011-07-27
K110703	Bd Autoshield Duo Pen Needle	Becton Dickinson & Co	FMI	Class II	2011-07-27
K110546	Medihoney Hydrogel Sheet Dressings with Active Leptospermum Honey	Derma Sciences, Inc.	FRO	Unclassified	2011-07-27
K110156	Ambulatory Bllod Pressure Monitor, Electronic Sphygmomanometer,	Contec Medical System Co., Ltd.	DXN	Class II	2011-07-27
K103694	Tissue Sampling Needle	United States Endoscopy Group, Inc.	FCG	Class II	2011-07-27
K111582	Logiq S8	GE Healthcare	IYN	Class II	2011-07-26
K111388	Diamondback 360* Orbital Atherectomy System, Stealth 360* Orbital Pad System	Cardiovascular Systems Incorporated	MCW	Class II	2011-07-26
K111209	Integrated Innova - S5i System Option	GE Healthcare	IZI	Class II	2011-07-26
K111187	Patch, Pledget and Intracardiac	Cormatrix Cardiovascular, Inc.	DXZ	Class II	2011-07-26
K110942	Pica Whole-Body MRI System	Time Medical Limited	LNH	Class II	2011-07-26
K110906	Apex Spine System	Spinecraft LLC	NKB	Class II	2011-07-26