Cleared Special

K041738 - BAXTER INFUSOR SV (SMALL VOLUME)

Also marketed or referenced as:
BAXTER INFUSOR LV (LARGE VOLUME)

K041738 is the FDA 510(k) clearance for BAXTER INFUSOR SV (SMALL VOLUME) by Baxter Healthcare Corporation. It is a Class 2 General Hospital device (product code FRN) cleared through the Special 510(k) pathway after a 11-day FDA review.

K041738 · Baxter Healthcare Corporation · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2004
Decision
11d
Days
Class 2
Risk

K041738 is an FDA 510(k) clearance for the BAXTER INFUSOR SV (SMALL VOLUME). Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Baxter Healthcare Corporation (Round Lake, US). The FDA issued a Cleared decision on July 9, 2004 after a review of 11 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Baxter Healthcare Corporation devices

Submission Details

510(k) Number K041738 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 2004
Decision Date July 09, 2004
Days to Decision 11 days
Submission Type Special
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
118d faster than avg
Panel avg: 129d · This submission: 11d
Pathway characteristics
Modification to existing cleared device.

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 435
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K041738.
PAINPUMP1
K042405 · Stryker Corp. · Oct 2004
HOSPIRA MEDNET MEDICATION MANAGEMENT SUITE
K042609 · Hospira, Inc. · Oct 2004
PLUM A+ INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE , AND PLUM A+3 INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE
K042081 · Hospira, Inc. · Aug 2004
HOSPIRA PHOENIX INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE
K041550 · Abbott Laboratories · Jun 2004
COLLEAGUE VOLUMETRIC INFUSION PUMPS
K041191 · Baxter Healthcare Corp · Jun 2004
MEDEX 3000 SERIES MR SYRINGE INFUSION PUMP
K040899 · Medex, Inc. · Apr 2004