Cleared Traditional

GUARDIAN, VOLUMETRIC CONTROL DELIVERY (K811933) - FDA 510(k) Clearance

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

K811933 · Avi, Inc. · General Hospital
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Jul 1981
Decision
14d
Days
Class 2
Risk

K811933 is an FDA 510(k) clearance for the GUARDIAN, VOLUMETRIC CONTROL DELIVERY. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Avi, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 20, 1981 after a review of 14 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5725 - 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 Avi, Inc. devices

Submission Details

510(k) Number K811933 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 1981
Decision Date July 20, 1981
Days to Decision 14 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
115d faster than avg
Panel avg: 129d · This submission: 14d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FRN Pump, Infusion
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5725
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 - FRN Pump, Infusion

All 235
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K811933.
FLO-GARD 8000 INFUSION PUMP SYSTEM
K813403 · Travenol Laboratories, S.A. · Dec 1981
3M INFUSION SYSTEM
K812442 · 3M Company · Sep 1981
TERUFUSION INFUSION PUMP MODEL STC-502
K812339 · Terumo Medical Corp. · Sep 1981
TRAVENOL INFUSION PUMP-2M8016
K802901 · Travenol Laboratories, S.A. · Dec 1980
TRAVENOL 24 HR. INFUSOR (ELASTOMERIC PP)
K802820 · Travenol Laboratories, S.A. · Dec 1980
CORDIS DOW INFUSION PUMP
K802301 · Cordis Corp. · Oct 1980