Cleared Traditional

K791496 - LOW PLASTICIZER ADMINISTRATION SETS

K791496 is the FDA 510(k) clearance for LOW PLASTICIZER ADMINISTRATION SETS by Travenol Laboratories, S.A.. It is a Class 2 General Hospital device (product code FPA) cleared through the Traditional 510(k) pathway after a 249-day FDA review.

K791496 · Travenol Laboratories, S.A. · General Hospital
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Apr 1980
Decision
249d
Days
Class 2
Risk

K791496 is an FDA 510(k) clearance for the LOW PLASTICIZER ADMINISTRATION SETS. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Travenol Laboratories, S.A. (Mchenry, US). The FDA issued a Cleared decision on April 8, 1980 after a review of 249 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5440 - 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 K791496 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 1979
Decision Date April 08, 1980
Days to Decision 249 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
120d slower than avg
Panel avg: 129d · This submission: 249d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FPA Set, Administration, Intravascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5440
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 - FPA Set, Administration, Intravascular

All 448
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K791496.
VOLUMETRIC PUMP CASSETTE W/ATTACHED SET
K800711 · Travenol Laboratories, S.A. · May 1980
MCGAW/EPIC I.V. ADMIN. SET
K800403 · American Hospital Supply Corp. · Apr 1980
B-D STASET, I.V. FLOW CONTROLLER
K800600 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1980
PRI. PIGGYBACK I.V. W/DUAL PIERCING PIN
K800137 · Abbott Laboratories · Mar 1980
VENTED I.V. SET
K792228 · Abbott Laboratories · Jan 1980
CONTINU-FLO ADMIN. SET CODE 2C/200
K792538 · Travenol Laboratories, S.A. · Dec 1979