Cleared Traditional

K041191 - COLLEAGUE VOLUMETRIC INFUSION PUMPS

K041191 is the FDA 510(k) clearance for COLLEAGUE VOLUMETRIC INFUSION PUMPS by Baxter Healthcare Corp. It is a Class 2 General Hospital device (product code FRN) cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K041191 · Baxter Healthcare Corp · General Hospital
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Optimized for regulatory review, auditing and printing
Jun 2004
Decision
50d
Days
Class 2
Risk

K041191 is an FDA 510(k) clearance for the COLLEAGUE VOLUMETRIC INFUSION PUMPS. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Baxter Healthcare Corp (Round Lake, US). The FDA issued a Cleared decision on June 25, 2004 after a review of 50 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 Baxter Healthcare Corp devices

Submission Details

510(k) Number K041191 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 2004
Decision Date June 25, 2004
Days to Decision 50 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
79d faster than avg
Panel avg: 129d · This submission: 50d
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 443
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K041191.
PLUM A+ INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE , AND PLUM A+3 INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE
K042081 · Hospira, Inc. · Aug 2004
BAXTER INFUSOR SV (SMALL VOLUME)
K041738 · Baxter Healthcare Corporation · Jul 2004
HOSPIRA PHOENIX INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE
K041550 · Abbott Laboratories · Jun 2004
MEDEX 3000 SERIES MR SYRINGE INFUSION PUMP
K040899 · Medex, Inc. · Apr 2004
MEDTRONIC MINIMED MMT-407C AMBULATORY INFUSION PUMP, MODEL MMT-407C
K040061 · Medtronic Minimed · Apr 2004
ABBOTT DATA PORT PC, MODEL 12181
K040114 · Abbott Laboratories · Jan 2004