Cleared Traditional

K860353 - SYRINGE INFUSION PUMP

K860353 is the FDA 510(k) clearance for SYRINGE 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 218-day FDA review.

K860353 · Travenol Laboratories, S.A. · General Hospital
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Sep 1986
Decision
218d
Days
Class 2
Risk

K860353 is an FDA 510(k) clearance for the SYRINGE INFUSION PUMP. 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 September 5, 1986 after a review of 218 days - an extended review 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: 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 K860353 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 30, 1986
Decision Date September 05, 1986
Days to Decision 218 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
89d slower than avg
Panel avg: 129d · This submission: 218d
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 K860353.
MODEL 504-S EXTERNAL INFUSION PUMP FOR DIABETICS
K864517 · Medtronic Minimed · Dec 1986
BARD HARVARD(TM) PCA JR INTERMITTENT INFUSION PUMP
K863683 · C.R. Bard, Inc. · Oct 1986
MODEL PC-2 VOLUMETRIC INFUSION PUMP/CONTROLLER
K862295 · Imed Corp. · Sep 1986
SOF SET, MODELS 111 AND 112
K861436 · Pacesetter Systems · Jun 1986
SOF SET, MODELS 113 AND 114
K860857 · Pacesetter Systems · May 1986
BECTON DICKINSON PCAINFUSER
K861007 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1986