Cleared Traditional

K840394 - STOPCOCKS & EXTENSION TUBES

K840394 is an FDA 510(k) clearance for STOPCOCKS & EXTENSION TUBES, manufactured by American Pharmaseal Div. Ahsc. The device is a Class 2 General Hospital device with product code FMG cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K840394 · American Pharmaseal Div. Ahsc · General Hospital
Download Printable Device Report (PDF)
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Mar 1984
Decision
49d
Days
Class 2
Risk

K840394 is an FDA 510(k) clearance for the STOPCOCKS & EXTENSION TUBES. Classified as Stopcock, I.v. Set (product code FMG), Class II - Special Controls.

Submitted by American Pharmaseal Div. Ahsc (Walker, US). The FDA issued a Cleared decision on March 19, 1984 after a review of 49 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 American Pharmaseal Div. Ahsc devices

FDA 510(k) Submission Details - K840394

510(k) Number K840394 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 30, 1984
Decision Date March 19, 1984
Days to Decision 49 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
80d faster than avg
Panel avg: 129d · This submission: 49d
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 41
Devices cleared under the same product code (FMG) and FDA review panel - the closest regulatory comparables to K840394.
CHURCHILL 3-WAY STOPCOCK
K864440 · Churchill Corp. · Jan 1987
CHURCHILL 3-WAY STOPCOCK SET
K854348 · Churchill Corp. · Nov 1985
CLICK LOCK MULTI-VAS INFECTION CONTROL MANIFOLD
K853275 · Icu Medical, Inc. · Aug 1985
PEDIATRIC EXTEN. SET FOR SECOND-DRUG
K830198 · Travenol Laboratories, S.A. · Feb 1983
TERUFUSION THREE-WAY STOPCOCK
K823469 · Terumo Medical Corp. · Dec 1982
ARTERIOGRAM TRAY
K812927 · American Pharmaseal Div. Ahsc · Nov 1981