Cleared Traditional

VOLUMETRIC INFUSION PUMP (K910024) - FDA 510(k) Clearance

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

K910024 · Baxter Healthcare Corp · General Hospital
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May 1991
Decision
148d
Days
Class 2
Risk

K910024 is an FDA 510(k) clearance for the VOLUMETRIC 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 May 31, 1991 after a review of 148 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

Submission Details

510(k) Number K910024 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 1991
Decision Date May 31, 1991
Days to Decision 148 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 slower than avg
Panel avg: 129d · This submission: 148d
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 219
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K910024.
EPIDURAL INDICATION FOR BAXTER INFUSORS ATTACHMENT
K905778 · Baxter Healthcare Corp · Jul 1991
BARD ALFENTANIL INFUSER
K904890 · C.R. Bard, Inc. · Jun 1991
FLO-GARD 6300 DUAL CHANNEL VOLUMETRIC INFUSION PUM
K910934 · Baxter Healthcare Corp · Jun 1991
ABBOTT LIFECARE 5000 PUMP
K911401 · Abbott Laboratories · May 1991
ABBOTT LIFECARE 5000 PUMP MODIFIED
K910919 · Abbott Laboratories · May 1991
EPIDURAL INDICATION FOR BAXTER SYRINGE INFUS PUMP
K911289 · Baxter Healthcare Corp · May 1991