Cleared Traditional

1424 TUMISTORE (K822914) - FDA 510(k) Clearance

K822914 · Life-Tech Intl., Inc. · Gastroenterology & Urology device
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Dec 1982
Decision
63d
Days
-
Risk

K822914 is an FDA 510(k) clearance for the 1424 TUMISTORE.

Submitted by Life-Tech Intl., Inc. (Walker, US). The FDA issued a Cleared decision on December 3, 1982 after a review of 63 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 Life-Tech Intl., Inc. devices

Submission Details

510(k) Number K822914 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 1982
Decision Date December 03, 1982
Days to Decision 63 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
67d faster than avg
Panel avg: 130d · This submission: 63d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -