Cleared Traditional

K830198 - PEDIATRIC EXTEN. SET FOR SECOND-DRUG

K830198 is an FDA 510(k) clearance for PEDIATRIC EXTEN. SET FOR SECOND-DRUG, manufactured by Travenol Laboratories, S.A.. The device is a Class 2 General Hospital device with 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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Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K830198

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.

FMG Device Classification - Class 2, Special Controls

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 85
Devices cleared under the same product code (FMG) and FDA review panel - the closest regulatory comparables to K830198.
VIGGO CONNECTA 3-WAY INFUSION STOPCOCK
K850280 · Viggo Products · Apr 1985
DISPOSABLE STOPCOCKS
K842173 · Procedure Products, Inc. · Sep 1984
STOPCOCKS & EXTENSION TUBES
K840394 · American Pharmaseal Div. Ahsc · Mar 1984
BENZING RETROGRADE ADMIN. SET
K823373 · Beech Medical, Inc. · Dec 1982
TERUFUSION THREE-WAY STOPCOCK
K823469 · Terumo Medical Corp. · Dec 1982
EXACTA & CONNECTA STOPCOCKS W/EXTENSION
K823120 · Pioneer Viggo, Inc. · Nov 1982
K830198 · PEDIATRIC EXTEN. SET FOR SECOND-DRUG
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