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
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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.

View all Shift Labs, Inc. devices

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 16
Devices cleared under the same product code (FLN) and FDA review panel - the closest regulatory comparables to K172242.
LEVELERT II FLUID LEVEL SENSOR
K060123 · Smith & Nephew, Inc. · Feb 2006
STRYKER L3 HYDROLERT
K022248 · Stryker Endoscopy · Aug 2002
FLUID CENTURION (4-100-00)
K973025 · Northgate Technologies, Inc. · Nov 1997
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M212
K972084 · Alexander Mfg. Co. · Jul 1997
SMITH & NEPHEW DYONICS LEVELERT SYSTEM
K903193 · Smith & Nephew Dyonics, Inc. · Aug 1990
TRAVENOL FLO-GARD 500 IV MONITOR
K850710 · Travenol Laboratories, S.A. · Apr 1985