Cleared Traditional

K831251 - TUMISENSOR 1524 (FDA 510(k) Clearance)

K831251 · Life-Tech Intl., Inc. · Gastroenterology & Urology device
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Jun 1983
Decision
46d
Days
-
Risk

K831251 is an FDA 510(k) clearance for the TUMISENSOR 1524. Classified as Monitor, Penile Tumescence (product code LIL).

Submitted by Life-Tech Intl., Inc. (Mchenry, US). The FDA issued a Cleared decision on June 3, 1983 after a review of 46 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 K831251 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 1983
Decision Date June 03, 1983
Days to Decision 46 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
84d faster than avg
Panel avg: 130d · This submission: 46d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LIL Monitor, Penile Tumescence
Device Class -