Cleared Traditional

K910934 - FLO-GARD 6300 DUAL CHANNEL VOLUMETRIC INFUSION PUM

K910934 is an FDA 510(k) clearance for FLO-GARD 6300 DUAL CHANNEL VOLUMETRIC I..., manufactured by Baxter Healthcare Corp. The device is a Class 2 General Hospital device with product code FRN cleared through the Traditional 510(k) pathway after a 110-day FDA review.

K910934 · Baxter Healthcare Corp · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1991
Decision
110d
Days
Class 2
Risk

K910934 is an FDA 510(k) clearance for the FLO-GARD 6300 DUAL CHANNEL VOLUMETRIC INFUSION PUM. 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 24, 1991 after a review of 110 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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

FDA 510(k) Submission Details - K910934

510(k) Number K910934 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 1991
Decision Date June 24, 1991
Days to Decision 110 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
19d faster than avg
Panel avg: 129d · This submission: 110d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FRN Device Classification - Class 2, Special Controls

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 601
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K910934.
BARD AMBULATORY PUMP TUBING SET
K905713 · C.R. Bard, Inc. · Jul 1991
EPIDURAL INDICATION FOR BAXTER INFUSORS ATTACHMENT
K905778 · Baxter Healthcare Corp · Jul 1991
BARD ALFENTANIL INFUSER
K904890 · C.R. Bard, Inc. · Jun 1991
MODEL 404-SP AND 504-SP INFUSION PUMPS MODIFIED
K912458 · Medtronic Minimed · Jun 1991
AVI MODEL 870 DUAL CHANNEL INFUSION PUMP
K912031 · 3M Avi, Inc. · Jun 1991
RATEMINDER(TM) V INFUSION PUMP, MODIFICATION
K911769 · Critikon Company, LLC · Jun 1991