Cleared Traditional

K891289 - FLO-GARD 6300 DUAL CHANNEL VOLUME INFUSION PUMP (FDA 510(k) Clearance)

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

K891289 · Baxter Healthcare Corp · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1990
Decision
329d
Days
Class 2
Risk

K891289 is an FDA 510(k) clearance for the FLO-GARD 6300 DUAL CHANNEL VOLUME INFUSION PUMP. 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 February 2, 1990 after a review of 329 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Baxter Healthcare Corp devices

Submission Details

510(k) Number K891289 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 1989
Decision Date February 02, 1990
Days to Decision 329 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
201d slower than avg
Panel avg: 128d · This submission: 329d
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 847
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K891289.
FreedomEdge Infusion System
K252015 · Koru Medical Systems, Inc. · Jan 2026
Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)
K251636 · Baxter Healthcare Corporation · Jul 2025
SIGMA Spectrum Infusion Pump with Master Drug Library
K251640 · Baxter Healthcare Corporation · Jul 2025
MRidium 3870 MRI Infusion Pump System (3870)
K242752 · Iradimed Corporation · May 2025
BD Alaris Infusion System with Guardrails Suite MX
K243855 · Carefusion 303, Inc. · Apr 2025
Plum Solo™ Precision IV Pump
K242114 · Icu Medical, Inc. · Apr 2025