Cleared Traditional

IVAC (R) SITE-SAVER (TM) VOLUMETRIC CONTROLLER 280 (K870317) - FDA 510(k) Clearance

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

K870317 · Y · General Hospital
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Apr 1987
Decision
65d
Days
Class 2
Risk

K870317 is an FDA 510(k) clearance for the IVAC (R) SITE-SAVER (TM) VOLUMETRIC CONTROLLER 280. Classified as Controller, Infusion, Intravascular, Electronic (product code LDR), Class II - Special Controls.

Submitted by Y (San Diego, US). The FDA issued a Cleared decision on April 3, 1987 after a review of 65 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 Y devices

Submission Details

510(k) Number K870317 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 28, 1987
Decision Date April 03, 1987
Days to Decision 65 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
64d faster than avg
Panel avg: 129d · This submission: 65d
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 10
Devices cleared under the same product code (LDR) and FDA review panel - the closest regulatory comparables to K870317.
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LIFECARE 75 CONTROLLER
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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