Cleared Traditional

DripAssist Plus

K172242 · Shift Labs, Inc. · General Hospital
May 2018
Decision
303d
Days
Class 2
Risk

About This 510(k) Submission

K172242 is an FDA 510(k) clearance for the DripAssist Plus, a Monitor, Electric For Gravity Flow Infusion Systems (Class II — Special Controls, product code FLN), submitted by Shift Labs, Inc. (Seattle, US). The FDA issued a Cleared decision on May 25, 2018, 303 days after receiving the submission on July 26, 2017. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.2420.

Submission Details

510(k) Number K172242 FDA.gov
FDA Decision Cleared SESE
Date Received July 26, 2017
Decision Date May 25, 2018
Days to Decision 303 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FLN — Monitor, Electric For Gravity Flow Infusion Systems
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.2420