Cleared Traditional

K782168 - 3-WAY STOPCOCK

K782168 is an FDA 510(k) clearance for 3-WAY STOPCOCK, manufactured by Medex, Inc.. The device is a Class 2 General Hospital device with product code FMG cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K782168 · Medex, Inc. · General Hospital
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Feb 1979
Decision
55d
Days
Class 2
Risk

K782168 is an FDA 510(k) clearance for the 3-WAY STOPCOCK. Classified as Stopcock, I.v. Set (product code FMG), Class II - Special Controls.

Submitted by Medex, Inc. (Walker, US). The FDA issued a Cleared decision on February 22, 1979 after a review of 55 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 Medex, Inc. devices

FDA 510(k) Submission Details - K782168

510(k) Number K782168 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 1978
Decision Date February 22, 1979
Days to Decision 55 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
74d faster than avg
Panel avg: 129d · This submission: 55d
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 54
Devices cleared under the same product code (FMG) and FDA review panel - the closest regulatory comparables to K782168.
ARTERIOGRAM TRAY
K812927 · American Pharmaseal Div. Ahsc · Nov 1981
STOPCOCK 2-WAY, 3-WAY & 4-WAY
K802258 · Stanco Medical, Inc. · Sep 1980
THREE-WAY STOPCOCK EXTENSION SET 20-SL
K800284 · Abbott Laboratories · Feb 1980
DELTA FLOW
K782167 · Medex, Inc. · Feb 1979
MANIFOLD, DISPOSABLE 3 VALVE
K790010 · Cordis Corp. · Feb 1979
SUPPLEMENTAL TYGON PAC-MONITORING LINES
K780662 · Norton Performance Plastics Corp. · Jun 1978