Cleared Traditional

K782134 - FILTER FOR HYPERALIMENTATION SET

K782134 is the FDA 510(k) clearance for FILTER FOR HYPERALIMENTATION SET 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 21-day FDA review.

K782134 · Travenol Laboratories, S.A. · General Hospital
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Jan 1979
Decision
21d
Days
Class 2
Risk

K782134 is an FDA 510(k) clearance for the FILTER FOR HYPERALIMENTATION SET. 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 January 17, 1979 after a review of 21 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Travenol Laboratories, S.A. devices

Submission Details

510(k) Number K782134 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 1978
Decision Date January 17, 1979
Days to Decision 21 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
108d faster than avg
Panel avg: 129d · This submission: 21d
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 K782134.
T-CONNECTOR
K790408 · Medex, Inc. · Apr 1979
FILTERSET 0.22, I.V. PUMP
K790108 · Imed Corp. · Mar 1979
SOLUTION ADMINISTRATION, TIP PROTECTOR
K781813 · Travenol Laboratories, S.A. · Jan 1979
MODEL IV 1500 STANDARD BURETTE
K781637 · Valleylab, Inc. · Dec 1978
SOLUTION ADMINISTRATION, FLEX VALVE
K781812 · Travenol Laboratories, S.A. · Dec 1978
AUTO-SYRINGE INFUSION SET
K781036 · Baxter Healthcare Corp · Aug 1978