Cleared Traditional

K832284 - SOLUTION ADMIN. SET 2C9096 W/10 PVC (FDA 510(k) Clearance)

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K832284 · Travenol Laboratories, S.A. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1983
Decision
169d
Days
Class 2
Risk

K832284 is an FDA 510(k) clearance for the SOLUTION ADMIN. SET 2C9096 W/10 PVC. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Travenol Laboratories, S.A. (Walker, US). The FDA issued a Cleared decision on December 29, 1983 after a review of 169 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 K832284 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 13, 1983
Decision Date December 29, 1983
Days to Decision 169 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
41d slower than avg
Panel avg: 128d · This submission: 169d
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 1173
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K832284.
PuraCath Firefly Needleless Connector IT (9005)
K251375 · Puracath Medical, Inc. · Feb 2026
nSet+ Stabilization Set [6426733]
K251257 · Np Medical · Dec 2025
BD Alaris Pump Infusion Set
K250325 · Carefusion (Bd) · Oct 2025
EZ™ IV Administration Set
K251814 · Epic Medical Pte. , Ltd. · Aug 2025
SteadiSet infusion set
K251854 · Tandem Diabetes Care · Aug 2025
Sparta Infusion Set for Insulin
K243841 · Deka Research and Development · Aug 2025