Cleared Traditional

IVY COMMANDER (MODEL 500) (K870820) - FDA 510(k) Clearance

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

K870820 · Ivy Medical, Inc. · General Hospital
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Jan 1988
Decision
323d
Days
Class 2
Risk

K870820 is an FDA 510(k) clearance for the IVY COMMANDER (MODEL 500). Classified as Controller, Infusion, Intravascular, Electronic (product code LDR), Class II - Special Controls.

Submitted by Ivy Medical, Inc. (Minneapolis, US). The FDA issued a Cleared decision on January 20, 1988 after a review of 323 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Ivy Medical, Inc. devices

Submission Details

510(k) Number K870820 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 1987
Decision Date January 20, 1988
Days to Decision 323 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
194d slower than avg
Panel avg: 129d · This submission: 323d
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 11
Devices cleared under the same product code (LDR) and FDA review panel - the closest regulatory comparables to K870820.
3M IV FLOW REGULATOR
K896907 · 3M Company · Feb 1990
LIFECARE 75 CONTROLLER
K893487 · Abbott Laboratories · Jul 1989
TECHNICON CHEM 1(TM) SYSTEM
K874916 · Technicon Instruments Corp. · Mar 1988
FLO-GARD 4000 VOLUMETRIC INFUSION CONTROLLER
K854863 · Travenol Laboratories, S.A. · Feb 1986
ABBOTT LIFECARE 1050 CONTROLLER
K842080 · Abbott Laboratories · Jul 1984
FLO-GARD 4000 VOLUMETRIC INFUSION
K840644 · Travenol Laboratories, S.A. · Mar 1984