Cleared Traditional

K870317 - IVAC SITE-SAVER (TM) VOLUMETRIC CONTROL...

K870317 is the FDA 510(k) clearance for IVAC SITE-SAVER (TM) VOLUMETRIC CONTROL... by Y. It is a Class 2 General Hospital device (product code LDR) cleared through the Traditional 510(k) pathway after a 65-day FDA review.

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
Combination Product No
PCCP Authorized No
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 28
Devices cleared under the same product code (LDR) and FDA review panel - the closest regulatory comparables to K870317.
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 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