Cleared Traditional

BD PureHub Disinfecting Cap

K193190 · Becton, Dickinson and Company · General Hospital

Nov 2020

Decision

356d

Days

Class 2

Risk

About This 510(k) Submission

K193190 is an FDA 510(k) clearance for the BD PureHub Disinfecting Cap, a Cap, Device Disinfectant (Class II — Special Controls, product code QBP), submitted by Becton, Dickinson and Company (Franklin Lakes, US). The FDA issued a Cleared decision on November 9, 2020, 356 days after receiving the submission on November 19, 2019. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number	K193190 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 19, 2019
Decision Date	November 09, 2020
Days to Decision	356 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