Cleared Traditional

K822849 - RAAF DUAL LUMEN CATHETER (FDA 510(k) Clearance)

K822849 · Quinton, Inc. · Gastroenterology & Urology device
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Nov 1982
Decision
67d
Days
-
Risk

K822849 is an FDA 510(k) clearance for the RAAF DUAL LUMEN CATHETER.

Submitted by Quinton, Inc. (Walker, US). The FDA issued a Cleared decision on November 29, 1982 after a review of 67 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel. 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 Quinton, Inc. devices

Submission Details

510(k) Number K822849 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 1982
Decision Date November 29, 1982
Days to Decision 67 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 130d · This submission: 67d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -