Cleared Traditional

CANYONS BI-DIRECTIONAL CHECK VALVE (K954181) - FDA 510(k) Clearance

Class I General Hospital device.

K954181 · Canyon Medical Products · General Hospital
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Nov 1995
Decision
84d
Days
Class 1
Risk

K954181 is an FDA 510(k) clearance for the CANYONS BI-DIRECTIONAL CHECK VALVE. Classified as Dispenser, Liquid Medication (product code KYX), Class I - General Controls.

Submitted by Canyon Medical Products (Salt Lake City, US). The FDA issued a Cleared decision on November 29, 1995 after a review of 84 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6430 - 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 Canyon Medical Products devices

Submission Details

510(k) Number K954181 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 1995
Decision Date November 29, 1995
Days to Decision 84 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 129d · This submission: 84d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KYX Dispenser, Liquid Medication
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6430
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.