Cleared Traditional

LARGE VOLUME ELASTOMERIC INFUSION DEVICE ATTACH. (K910425) - FDA 510(k) Clearance

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

K910425 · Baxter Healthcare Corp · General Hospital
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Apr 1991
Decision
60d
Days
Class 2
Risk

K910425 is an FDA 510(k) clearance for the LARGE VOLUME ELASTOMERIC INFUSION DEVICE ATTACH.. 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 April 1, 1991 after a review of 60 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 K910425 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 1991
Decision Date April 01, 1991
Days to Decision 60 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
69d faster than avg
Panel avg: 129d · This submission: 60d
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 K910425.
EPIDURAL INDICATION FOR BAXTER SYRINGE INFUS PUMP
K911289 · Baxter Healthcare Corp · May 1991
BARD PCA II PUMP WITH PROGRAM CARTRIDGES
K902613 · C.R. Bard, Inc. · Apr 1991
EPIDURAL INDICATION FOR VOLUMETRIC INFUSION PUMPS
K910428 · Baxter Healthcare Corp · Apr 1991
MODIFIED VOLUMETRIC INFUSION PUMPS ATTACHMENTS
K910523 · Baxter Healthcare Corp · Mar 1991
BARD AMBULATORY PCA DRUG DELIVERY SYSTEM
K904403 · C.R. Bard, Inc. · Dec 1990
SYRINGE INFUSION PUMP
K903343 · Baxter Healthcare Corp · Nov 1990