Cleared Traditional

K932408 - AMBULATORY INFUSION PUMP SYSTEM AND SOLUTION SETS (FDA 510(k) Clearance)

Class I Gastroenterology & Urology device.

K932408 · Baxter Healthcare Corp · Gastroenterology & Urology device
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Sep 1993
Decision
133d
Days
Class 1
Risk

K932408 is an FDA 510(k) clearance for the AMBULATORY INFUSION PUMP SYSTEM AND SOLUTION SETS. Classified as Clamp, Non-electrical (product code FFN), Class I - General Controls.

Submitted by Baxter Healthcare Corp (Round Lake, US). The FDA issued a Cleared decision on September 28, 1993 after a review of 133 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4730 - the FDA gastroenterology and urology 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 Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K932408 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 1993
Decision Date September 28, 1993
Days to Decision 133 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
3d slower than avg
Panel avg: 130d · This submission: 133d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FFN Clamp, Non-electrical
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 876.4730
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.