Cleared Traditional

IVAC VARIABLE PRESSURE VOLUMETRIC PUMP, 570 SERIES (K891583) - FDA 510(k) Clearance

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

K891583 · Y · General Hospital
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Jun 1989
Decision
81d
Days
Class 2
Risk

K891583 is an FDA 510(k) clearance for the IVAC VARIABLE PRESSURE VOLUMETRIC PUMP, 570 SERIES. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Y (San Diego, US). The FDA issued a Cleared decision on June 9, 1989 after a review of 81 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 K891583 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 1989
Decision Date June 09, 1989
Days to Decision 81 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
48d faster than avg
Panel avg: 129d · This submission: 81d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FRN Pump, Infusion
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 - FRN Pump, Infusion

All 221
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K891583.
LIFECARE MICRO PUMP
K883645 · Abbott Laboratories · Aug 1989
60 MICROBORE EXTENSION SET W/ANTI-SIPHON VALVE
K892906 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jul 1989
BASAL/BOLUS INFUSORS
K884505 · Baxter Healthcare Corp · Jul 1989
RESUBMITTED ABBOTT LIFECARE MODEL 3 HB PUMP
K890282 · Abbott Laboratories · Apr 1989
LIFECARE MICRO PUMP
K883796 · Abbott Laboratories · Feb 1989
FLO-GARD VP
K884014 · Baxter Healthcare Corp · Dec 1988