Cleared Traditional

K823404 - VOLUMERIC CONTROLLER

K823404 is the FDA 510(k) clearance for VOLUMERIC CONTROLLER by Quest Medical, Inc.. It is a Class 2 General Hospital device (product code LDR) cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K823404 · Quest Medical, Inc. · General Hospital
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Dec 1982
Decision
37d
Days
Class 2
Risk

K823404 is an FDA 510(k) clearance for the VOLUMERIC CONTROLLER. Classified as Controller, Infusion, Intravascular, Electronic (product code LDR), Class II - Special Controls.

Submitted by Quest Medical, Inc. (Walker, US). The FDA issued a Cleared decision on December 22, 1982 after a review of 37 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 Quest Medical, Inc. devices

Submission Details

510(k) Number K823404 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 1982
Decision Date December 22, 1982
Days to Decision 37 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 129d · This submission: 37d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LDR Controller, Infusion, Intravascular, Electronic
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 - LDR Controller, Infusion, Intravascular, Electronic

All 26
Devices cleared under the same product code (LDR) and FDA review panel - the closest regulatory comparables to K823404.
FLO-GARD 4000 VOLUMETRIC INFUSION
K840644 · Travenol Laboratories, S.A. · Mar 1984
MODEL 2001 INTELLIGENT INFUSOR
K834528 · Quest Medical, Inc. · Feb 1984
FLO-GARD 8000 COMPUTER CONTROL INFUSI
K834154 · Travenol Laboratories, S.A. · Jan 1984
380 PIGGYBACK CONTROLLER
K823026 · Imed Corp. · Nov 1982
TRAVENOL INFUSION CONTROLLER 2M8052
K812510 · Travenol Laboratories, S.A. · Sep 1981
LIFECARE 1000 CONTROLLER
K812114 · Abbott Laboratories · Aug 1981