Cleared Traditional

K863864 - AMBULATORY INFUSION PUMP, MODEL AS30C

K863864 is an FDA 510(k) clearance for AMBULATORY INFUSION PUMP, manufactured by Travenol Laboratories, S.A.. The device is a Class 2 General Hospital device with 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

FDA 510(k) Submission Details - K863864

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.

FRN Device Classification - Class 2, Special Controls

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 582
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