Cleared Traditional

INFUSSION ALARM SYSTEM I.A.S. CAT.#1118 (K802011) - FDA 510(k) Clearance

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

K802011 · Pollak (Intl.), Ltd. · General Hospital
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Oct 1980
Decision
72d
Days
Class 2
Risk

K802011 is an FDA 510(k) clearance for the INFUSSION ALARM SYSTEM I.A.S. CAT.#1118. Classified as Monitor, Electric For Gravity Flow Infusion Systems (product code FLN), Class II - Special Controls.

Submitted by Pollak (Intl.), Ltd. (Mchenry, US). The FDA issued a Cleared decision on October 31, 1980 after a review of 72 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Pollak (Intl.), Ltd. devices

Submission Details

510(k) Number K802011 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 1980
Decision Date October 31, 1980
Days to Decision 72 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
57d faster than avg
Panel avg: 129d · This submission: 72d
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 K802011.
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