Cleared Traditional

K842209 - ARM-A-FLOW INTRAVENOUS FLOW REGULATOR

K842209 is the FDA 510(k) clearance for ARM-A-FLOW INTRAVENOUS FLOW REGULATOR by Armour Pharmaceutical Co.. It is a Class 2 General Hospital device (product code LDR) cleared through the Traditional 510(k) pathway after a 183-day FDA review.

K842209 · Armour Pharmaceutical Co. · General Hospital
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Dec 1984
Decision
183d
Days
Class 2
Risk

K842209 is an FDA 510(k) clearance for the ARM-A-FLOW INTRAVENOUS FLOW REGULATOR. Classified as Controller, Infusion, Intravascular, Electronic (product code LDR), Class II - Special Controls.

Submitted by Armour Pharmaceutical Co. (Mchenry, US). The FDA issued a Cleared decision on December 4, 1984 after a review of 183 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. 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 Armour Pharmaceutical Co. devices

Submission Details

510(k) Number K842209 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 1984
Decision Date December 04, 1984
Days to Decision 183 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
54d slower than avg
Panel avg: 129d · This submission: 183d
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 20
Devices cleared under the same product code (LDR) and FDA review panel - the closest regulatory comparables to K842209.
IVAC FLOW CONTROL ADMINISTRATION SET
K870132 · Y · Feb 1987
FLO-GARD 4000 VOLUMETRIC INFUSION CONTROLLER
K854863 · Travenol Laboratories, S.A. · Feb 1986
RATEMINDER III INFUSION DEVICE
K855000 · American Edwards Laboratories · Feb 1986
IVAC 280 VOLUMETRIC INFUSION CONTROLLER
K842419 · Y · Aug 1984
ABBOTT LIFECARE 1050 CONTROLLER
K842080 · Abbott Laboratories · Jul 1984
FLO-GARD 4000 VOLUMETRIC INFUSION
K840644 · Travenol Laboratories, S.A. · Mar 1984