Cleared Traditional

K791496 - LOW PLASTICIZER ADMINISTRATION SETS

K791496 is an FDA 510(k) clearance for LOW PLASTICIZER ADMINISTRATION SETS, manufactured by Travenol Laboratories, S.A.. The device is a Class 2 General Hospital device with 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

FDA 510(k) Submission Details - K791496

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.

FPA Device Classification - Class 2, Special Controls

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 772
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K791496.
Y-TYPE INFUSION SET (2 LEAD)
K800358 · Haemonetics Corp. · Apr 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