Cleared Traditional

K761151 - INFUSION PUMP

K761151 is the FDA 510(k) clearance for INFUSION PUMP 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 10-day FDA review.

K761151 · Travenol Laboratories, S.A. · General Hospital
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Dec 1976
Decision
10d
Days
Class 2
Risk

K761151 is an FDA 510(k) clearance for the 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 December 9, 1976 after a review of 10 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 Travenol Laboratories, S.A. devices

Submission Details

510(k) Number K761151 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 29, 1976
Decision Date December 09, 1976
Days to Decision 10 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
119d faster than avg
Panel avg: 129d · This submission: 10d
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 K761151.
VOLUMETRIC INFUSION PUMP MODEL 960
K771664 · Imed Corp. · Sep 1977
I.V. PUMP, ABBOTT/SHAW LIFECARE
K770087 · Abbott Laboratories · Feb 1977
AUTO SYRINGE MODEL AS-3A
K761307 · Baxter Healthcare Corp · Jan 1977
PERISTALTIC INFUSION PUMP (2100,2101)
K760718 · Extracorporeal Medical Specialities, Inc. · Oct 1976
INFUSION EQUIPMENT, INTRAVENOUS
K760370 · Valleylab, Inc. · Aug 1976