Cleared Traditional

K874181 - BAXTER BEDSIDE SYSTEM

K874181 is the FDA 510(k) clearance for BAXTER BEDSIDE SYSTEM by Travenol Laboratories, S.A.. It is a Class 2 General Hospital device (product code FRN) cleared through the Traditional 510(k) pathway after a 131-day FDA review.

K874181 · Travenol Laboratories, S.A. · General Hospital
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Feb 1988
Decision
131d
Days
Class 2
Risk

K874181 is an FDA 510(k) clearance for the BAXTER BEDSIDE SYSTEM. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Travenol Laboratories, S.A. (Round Lake, US). The FDA issued a Cleared decision on February 22, 1988 after a review of 131 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 Travenol Laboratories, S.A. devices

Submission Details

510(k) Number K874181 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 14, 1987
Decision Date February 22, 1988
Days to Decision 131 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
2d slower than avg
Panel avg: 129d · This submission: 131d
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 433
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K874181.
HALF HOUR INFUSOR
K880625 · Baxter Healthcare Corp · Apr 1988
MODIFIED PCA INFUSER
K875364 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1988
RATEMINDER V INFUSION PUMP
K875174 · Critikon Company, LLC · Mar 1988
MINIMED III INFUSION PUMP & UNI-SET ADMIN SET
K874564 · Medtronic Minimed · Feb 1988
CADD-PLUS(TM) MODEL 5400 AMBULATORY INFUSION PUMP
K874649 · Pharmacia Deltec, Inc. · Jan 1988
MODEL 3000 INFUSION PUMP
K871881 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jan 1988