Cleared Traditional

K834528 - MODEL 2001 INTELLIGENT INFUSOR

K834528 is the FDA 510(k) clearance for MODEL 2001 INTELLIGENT INFUSOR by Quest Medical, Inc.. It is a Class 2 General Hospital device (product code LDR) cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K834528 · Quest Medical, Inc. · General Hospital
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Feb 1984
Decision
62d
Days
Class 2
Risk

K834528 is an FDA 510(k) clearance for the MODEL 2001 INTELLIGENT INFUSOR. Classified as Controller, Infusion, Intravascular, Electronic (product code LDR), Class II - Special Controls.

Submitted by Quest Medical, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 21, 1984 after a review of 62 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 K834528 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 1983
Decision Date February 21, 1984
Days to Decision 62 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
67d faster than avg
Panel avg: 129d · This submission: 62d
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 K834528.
ABBOTT LIFECARE 1050 CONTROLLER
K842080 · Abbott Laboratories · Jul 1984
INTRAVENOUS INFUSION CONTROLLER
K834106 · Cutter Laboratories, Inc. · May 1984
FLO-GARD 4000 VOLUMETRIC INFUSION
K840644 · Travenol Laboratories, S.A. · Mar 1984
FLO-GARD 8000 COMPUTER CONTROL INFUSI
K834154 · Travenol Laboratories, S.A. · Jan 1984
VOLUMERIC CONTROLLER
K823404 · Quest Medical, Inc. · Dec 1982
380 PIGGYBACK CONTROLLER
K823026 · Imed Corp. · Nov 1982