Cleared Traditional

K800627 - AMBULATORY INFUSION PUMP

K800627 is the FDA 510(k) clearance for AMBULATORY 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 117-day FDA review.

K800627 · Travenol Laboratories, S.A. · General Hospital
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Jul 1980
Decision
117d
Days
Class 2
Risk

K800627 is an FDA 510(k) clearance for the AMBULATORY INFUSION PUMP, CODE 2M9807. 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 July 14, 1980 after a review of 117 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 K800627 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 19, 1980
Decision Date July 14, 1980
Days to Decision 117 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
12d faster than avg
Panel avg: 129d · This submission: 117d
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 K800627.
CORDIS DOW INFUSION PUMP
K802301 · Cordis Corp. · Oct 1980
THE SIMPLICITY PUMP #2100 INFUSION PUMP
K801546 · Critikon Company, LLC · Aug 1980
ABBOTT/SHAW LIFE CARE PUMP MODEL 3
K801441 · Abbott Laboratories · Aug 1980
INTRAVENOUS INFUSION PUMP, CODE 2M8015
K800629 · Travenol Laboratories, S.A. · May 1980
HEPARIN PUMP #7420
K800570 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1980
3M SMALL VOLUME INFUSTION (SVI) SYSTEM
K792050 · 3M Company · Mar 1980