Cleared Traditional

K851447 - IVAC MODEL 580 GENER. USE VOLUMETRIC IN...

K851447 is the FDA 510(k) clearance for IVAC MODEL 580 GENER. USE VOLUMETRIC IN... by Y. It is a Class 2 General Hospital device (product code FRN) cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K851447 · Y · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1985
Decision
44d
Days
Class 2
Risk

K851447 is an FDA 510(k) clearance for the IVAC MODEL 580 GENER. USE VOLUMETRIC INFUSION PUMP. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Y (San Diego, US). The FDA issued a Cleared decision on May 8, 1985 after a review of 44 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 K851447 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 25, 1985
Decision Date May 08, 1985
Days to Decision 44 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
85d faster than avg
Panel avg: 129d · This submission: 44d
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 447
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K851447.
VIAL SYRINGE PUMPS, SE200, SE200B & SE400
K852073 · Hospal Medical Corp. · Jun 1985
MODEL 2000 INDULIN INFUSION PUMP
K851564 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1985
IMED GRAVISET INTRAVASCULAR ADMIN. SET
K851360 · Imed Corp. · May 1985
QUEST 521 VARIABLE PRESSURE VOLUMETRIC INFUSION PU
K851017 · Quest Medical, Inc. · May 1985
IMED 440 INFUSION PUMP & ADMINISTRATION SET
K850653 · Imed Corp. · Apr 1985
PROMINJECT PROGRAMMABLE INFUSION PUMP
K850669 · Pharmacia, Inc. · Apr 1985