Cleared Traditional

K172242 - DripAssist Plus

K172242 is an FDA 510(k) clearance for DripAssist Plus, manufactured by Shift Labs, Inc.. The device is a Class 2 General Hospital device with product code FLN cleared through the Traditional 510(k) pathway after a 303-day FDA review.

K172242 · Shift Labs, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2018
Decision
303d
Days
Class 2
Risk

K172242 is an FDA 510(k) clearance for the DripAssist Plus. Classified as Monitor, Electric For Gravity Flow Infusion Systems (product code FLN), Class II - Special Controls.

Submitted by Shift Labs, Inc. (Seattle, US). The FDA issued a Cleared decision on May 25, 2018 after a review of 303 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.2420 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K172242

510(k) Number K172242 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
174d slower than avg
Panel avg: 129d · This submission: 303d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FLN Device Classification - Class 2, Special Controls

Product Code FLN Monitor, Electric For Gravity Flow Infusion Systems
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.2420
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - FLN Monitor, Electric For Gravity Flow Infusion Systems

All 25
Devices cleared under the same product code (FLN) and FDA review panel - the closest regulatory comparables to K172242.
DripAssist
K150687 · Shift Labs · Oct 2015
FLUID LEVEL MONITOR
K133870 · Coleman Laboratories · Apr 2014
LOW FLUID ALARM
K080704 · Em-Tec GmbH · Apr 2008
ISSYS DRUG FLOW MONITOR
K050783 · Integrated Sensing Systems, Inc. · Feb 2006
LEVELERT II FLUID LEVEL SENSOR
K060123 · Smith & Nephew, Inc. · Feb 2006
DRIP ALERT
K030136 · Drip Alert, Inc. · Apr 2003
K172242 · DripAssist Plus
Download PDF FDA Summary Shift Labs, Inc.