Cleared Traditional

ISSYS DRUG FLOW MONITOR (K050783) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K050783 · Integrated Sensing Systems, Inc. · General Hospital
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Feb 2006
Decision
331d
Days
Class 2
Risk

K050783 is an FDA 510(k) clearance for the ISSYS DRUG FLOW MONITOR. Classified as Monitor, Electric For Gravity Flow Infusion Systems (product code FLN), Class II - Special Controls.

Submitted by Integrated Sensing Systems, Inc. (Ypsilanti, US). The FDA issued a Cleared decision on February 22, 2006 after a review of 331 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 Integrated Sensing Systems, Inc. devices

Submission Details

510(k) Number K050783 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 2005
Decision Date February 22, 2006
Days to Decision 331 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
202d slower than avg
Panel avg: 129d · This submission: 331d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 38
Devices cleared under the same product code (FLN) and FDA review panel - the closest regulatory comparables to K050783.
DripAssist Plus
K172242 · Shift Labs, Inc. · May 2018
LEVELERT II FLUID LEVEL SENSOR
K060123 · Smith & Nephew, Inc. · Feb 2006
TRAVENOL FLO-GARD 500 IV MONITOR
K850710 · Travenol Laboratories, S.A. · Apr 1985
MODEL AS* 7B AUTOSYRINGE INFUSION PUMP
K802166 · Baxter Healthcare Corp · Nov 1980
PARENTERAL INFUSION CONTROLLER
K780223 · Travenol Laboratories, S.A. · Apr 1978