Cleared Traditional

K863864 - AMBULATORY INFUSION PUMP

K863864 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 124-day FDA review.

K863864 · Travenol Laboratories, S.A. · General Hospital
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Feb 1987
Decision
124d
Days
Class 2
Risk

K863864 is an FDA 510(k) clearance for the AMBULATORY INFUSION PUMP, MODEL AS30C. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Travenol Laboratories, S.A. (Hooksett, US). The FDA issued a Cleared decision on February 4, 1987 after a review of 124 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 K863864 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 1986
Decision Date February 04, 1987
Days to Decision 124 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
5d faster than avg
Panel avg: 129d · This submission: 124d
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 K863864.
ABBOTT LIFECARE (R) 5000, PUMP SYSTEM
K865058 · Abbott Laboratories · Feb 1987
I.V. SET W/SINGLE-CHANNEL CASSETTE
K865059 · Abbott Laboratories · Feb 1987
I.V. SET WITH DUAL-CHANNEL CASSETTE
K865060 · Abbott Laboratories · Feb 1987
STRATO(R) PCA INFUSER
K864808 · Strato Medical Corp. · Jan 1987
PERCUPUMP (TM)
K864227 · E-Z-Em, Inc. · Jan 1987
BARD HARVARD MINI-INFUSER 950 PUMP
K864233 · C.R. Bard, Inc. · Jan 1987