Cleared Traditional

K800629 - INTRAVENOUS INFUSION PUMP

K800629 is the FDA 510(k) clearance for INTRAVENOUS 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 55-day FDA review.

K800629 · Travenol Laboratories, S.A. · General Hospital
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May 1980
Decision
55d
Days
Class 2
Risk

K800629 is an FDA 510(k) clearance for the INTRAVENOUS INFUSION PUMP, CODE 2M8015. 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 May 14, 1980 after a review of 55 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 K800629 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 1980
Decision Date May 14, 1980
Days to Decision 55 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
74d faster than avg
Panel avg: 129d · This submission: 55d
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 K800629.
THE SIMPLICITY PUMP #2100 INFUSION PUMP
K801546 · Critikon Company, LLC · Aug 1980
ABBOTT/SHAW LIFE CARE PUMP MODEL 3
K801441 · Abbott Laboratories · Aug 1980
AMBULATORY INFUSION PUMP, CODE 2M9807
K800627 · Travenol Laboratories, S.A. · Jul 1980
HEPARIN PUMP #7420
K800570 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1980
3M SMALL VOLUME INFUSTION (SVI) SYSTEM
K792050 · 3M Company · Mar 1980
MODEL IV 6500 FORMULATOR
K792142 · Valleylab, Inc. · Nov 1979