Cleared Traditional

HALF HOUR INFUSOR (K880625) - FDA 510(k) Clearance

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

K880625 · Baxter Healthcare Corp · General Hospital
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Apr 1988
Decision
63d
Days
Class 2
Risk

K880625 is an FDA 510(k) clearance for the HALF HOUR INFUSOR. 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 19, 1988 after a review of 63 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 K880625 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 16, 1988
Decision Date April 19, 1988
Days to Decision 63 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
66d faster than avg
Panel avg: 129d · This submission: 63d
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 K880625.
BARD INFUSOR PUMP
K883577 · C.R. Bard, Inc. · Nov 1988
BECTON DICKINSON PCA INFUSER - SOFTWARE MODIFI.
K882556 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1988
BARD PCA II INFUSION PUMP
K880733 · C.R. Bard, Inc. · Jun 1988
MODIFIED PCA INFUSER
K875364 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1988
BAXTER BEDSIDE SYSTEM
K874181 · Travenol Laboratories, S.A. · Feb 1988
MODEL 3000 INFUSION PUMP
K871881 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jan 1988