Cleared Traditional

DripAssist

K150687 · Shift Labs · General Hospital
Oct 2015
Decision
210d
Days
Class 2
Risk

About This 510(k) Submission

K150687 is an FDA 510(k) clearance for the DripAssist, a Monitor, Electric For Gravity Flow Infusion Systems (Class II — Special Controls, product code FLN), submitted by Shift Labs (Seattle, US). The FDA issued a Cleared decision on October 13, 2015, 210 days after receiving the submission on March 17, 2015. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.2420.

Submission Details

510(k) Number K150687 FDA.gov
FDA Decision Cleared SESE
Date Received March 17, 2015
Decision Date October 13, 2015
Days to Decision 210 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