Cleared Traditional

K831534 - PUMPETTE AS8P-INFUSION PUMP (FDA 510(k) Clearance)

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

K831534 · Travenol Laboratories, S.A. · General Hospital
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Sep 1983
Decision
123d
Days
Class 2
Risk

K831534 is an FDA 510(k) clearance for the PUMPETTE AS8P-INFUSION PUMP. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Travenol Laboratories, S.A. (Mchenry, US). The FDA issued a Cleared decision on September 12, 1983 after a review of 123 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 K831534 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 1983
Decision Date September 12, 1983
Days to Decision 123 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
5d faster than avg
Panel avg: 128d · This submission: 123d
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 847
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