Cleared Traditional

SwabTip Male Disinfectant Cap

K190918 · Icu Medical · General Hospital

Mar 2020

Decision

332d

Days

Class 2

Risk

About This 510(k) Submission

K190918 is an FDA 510(k) clearance for the SwabTip Male Disinfectant Cap, a Cap, Device Disinfectant (Class II — Special Controls, product code QBP), submitted by Icu Medical (Lake Forest, US). The FDA issued a Cleared decision on March 6, 2020, 332 days after receiving the submission on April 9, 2019. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number	K190918 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 09, 2019
Decision Date	March 06, 2020
Days to Decision	332 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF

Device Classification

Product Code	QBP — Cap, Device Disinfectant
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 880.5440
Definition	Disinfect Needleless Access Valves And May Act As A Physical Barrier To Contamination If Not Removed For A Set Period Of Time