Cleared Traditional

K150687 - DripAssist

K150687 is an FDA 510(k) clearance for DripAssist, manufactured by Shift Labs. The device is a Class 2 General Hospital device with product code FLN cleared through the Traditional 510(k) pathway after a 210-day FDA review.

K150687 · Shift Labs · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2015
Decision
210d
Days
Class 2
Risk

K150687 is an FDA 510(k) clearance for the DripAssist. Classified as Monitor, Electric For Gravity Flow Infusion Systems (product code FLN), Class II - Special Controls.

Submitted by Shift Labs (Seattle, US). The FDA issued a Cleared decision on October 13, 2015 after a review of 210 days - an extended review cycle.

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. Standard predicate reliance. 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 - K150687

510(k) Number K150687 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
81d slower than avg
Panel avg: 129d · This submission: 210d
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 Consultant

Drug and Device Development Co., Inc.
Steven Chernoff

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K150687.
DripAssist Plus
K172242 · Shift Labs, Inc. · May 2018
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
K150687 · DripAssist
Download PDF FDA Summary Shift Labs