Cleared Traditional

K802258 - STOPCOCK 2-WAY

K802258 is the FDA 510(k) clearance for STOPCOCK 2-WAY by Stanco Medical, Inc.. It is a Class 2 General Hospital device (product code FMG) cleared through the Traditional 510(k) pathway after a 10-day FDA review.

K802258 · Stanco Medical, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1980
Decision
10d
Days
Class 2
Risk

K802258 is an FDA 510(k) clearance for the STOPCOCK 2-WAY, 3-WAY & 4-WAY. Classified as Stopcock, I.v. Set (product code FMG), Class II - Special Controls.

Submitted by Stanco Medical, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 26, 1980 after a review of 10 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 Stanco Medical, Inc. devices

Submission Details

510(k) Number K802258 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 1980
Decision Date September 26, 1980
Days to Decision 10 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
119d faster than avg
Panel avg: 129d · This submission: 10d
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 28
Devices cleared under the same product code (FMG) and FDA review panel - the closest regulatory comparables to K802258.
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
THREE-WAY STOPCOCK EXTENSION SET 20-SL
K800284 · Abbott Laboratories · Feb 1980
MANIFOLD, DISPOSABLE 3 VALVE
K790010 · Cordis Corp. · Feb 1979
STOPCOCK
K780596 · Abco Dealers, Inc. · Apr 1978