Cleared Traditional

K842905 - TRAVENOL MULTIDAY INFUSOR 2C1080

K842905 is the FDA 510(k) clearance for TRAVENOL MULTIDAY INFUSOR 2C1080 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 465-day FDA review.

K842905 · Travenol Laboratories, S.A. · General Hospital
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Nov 1985
Decision
465d
Days
Class 2
Risk

K842905 is an FDA 510(k) clearance for the TRAVENOL MULTIDAY INFUSOR 2C1080. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Travenol Laboratories, S.A. (Deerfield, US). The FDA issued a Cleared decision on November 1, 1985 after a review of 465 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Travenol Laboratories, S.A. devices

Submission Details

510(k) Number K842905 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 1984
Decision Date November 01, 1985
Days to Decision 465 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
336d slower than avg
Panel avg: 129d · This submission: 465d
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 K842905.
MP0400 ADULT, PERISTALIC INFUSION PUMP
K853814 · Medex, Inc. · Jan 1986
THE TRAVENOL 5 ML/HR INFUSOR
K853881 · Travenol Laboratories, S.A. · Dec 1985
NATIONAL MED CARE INFUSION PUMP ADM SET #95-0001-8
K853134 · Erika, Inc. · Nov 1985
SYRINGE INFUSION PUMP - AS 20 SERIES
K852358 · Baxter Healthcare Corp · Jul 1985
INFUSION SETS MODELS 9120,9121,9125, 9122 & 9123
K852060 · Cardiac Pacemakers, Inc. · Jun 1985
VIAL SYRINGE PUMPS, SE200, SE200B & SE400
K852073 · Hospal Medical Corp. · Jun 1985