Cleared Traditional

K830198 - PEDIATRIC EXTEN. SET FOR SECOND-DRUG

K830198 is the FDA 510(k) clearance for PEDIATRIC EXTEN. SET FOR SECOND-DRUG by Travenol Laboratories, S.A.. It is a Class 2 General Hospital device (product code FMG) cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K830198 · Travenol Laboratories, S.A. · General Hospital
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Feb 1983
Decision
18d
Days
Class 2
Risk

K830198 is an FDA 510(k) clearance for the PEDIATRIC EXTEN. SET FOR SECOND-DRUG. Classified as Stopcock, I.v. Set (product code FMG), Class II - Special Controls.

Submitted by Travenol Laboratories, S.A. (Walker, US). The FDA issued a Cleared decision on February 7, 1983 after a review of 18 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 K830198 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 20, 1983
Decision Date February 07, 1983
Days to Decision 18 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
111d faster than avg
Panel avg: 129d · This submission: 18d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FMG Stopcock, I.v. Set
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 - FMG Stopcock, I.v. Set

All 37
Devices cleared under the same product code (FMG) and FDA review panel - the closest regulatory comparables to K830198.
CHURCHILL 3-WAY STOPCOCK SET
K854348 · Churchill Corp. · Nov 1985
CLICK LOCK MULTI-VAS INFECTION CONTROL MANIFOLD
K853275 · Icu Medical, Inc. · Aug 1985
STOPCOCKS & EXTENSION TUBES
K840394 · American Pharmaseal Div. Ahsc · Mar 1984
TERUFUSION THREE-WAY STOPCOCK
K823469 · Terumo Medical Corp. · Dec 1982
ARTERIOGRAM TRAY
K812927 · American Pharmaseal Div. Ahsc · Nov 1981
THREE-WAY STOPCOCK EXTENSION SET 20-SL
K800284 · Abbott Laboratories · Feb 1980