Cleared Traditional

K870820 - IVY COMMANDER (MODEL 500)

K870820 is an FDA 510(k) clearance for IVY COMMANDER (MODEL 500), manufactured by Ivy Medical, Inc.. The device is a Class 2 General Hospital device with product code LDR cleared through the Traditional 510(k) pathway after a 323-day FDA review.

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

FDA 510(k) Submission Details - K870820

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.

LDR Device Classification - Class 2, Special Controls

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 33
Devices cleared under the same product code (LDR) and FDA review panel - the closest regulatory comparables to K870820.
IVAC(R) VOLUMETRIC CONTROLLER - MODEL 290
K874481 · Y · Mar 1988
TECHNICON CHEM 1(TM) SYSTEM
K874916 · Technicon Instruments Corp. · Mar 1988
IVAC(R) SITE-SAVER(R) VOLUMETRIC CONTROLLER - 280+
K874491 · Y · Feb 1988
IVAC (R) SITE-SAVER (TM) VOLUMETRIC CONTROLLER 280
K870317 · Y · Apr 1987
IVAC FLOW CONTROL ADMINISTRATION SET
K870132 · Y · Feb 1987
FLO-GARD 4000 VOLUMETRIC INFUSION CONTROLLER
K854863 · Travenol Laboratories, S.A. · Feb 1986