Cleared Traditional

K831252 - TUMISTORE RECORDER 1311 (FDA 510(k) Clearance)

K831252 · Life-Tech Intl., Inc. · Gastroenterology & Urology device
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May 1983
Decision
30d
Days
-
Risk

K831252 is an FDA 510(k) clearance for the TUMISTORE RECORDER 1311. Classified as Monitor, Penile Tumescence (product code LIL).

Submitted by Life-Tech Intl., Inc. (Mchenry, US). The FDA issued a Cleared decision on May 18, 1983 after a review of 30 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 K831252 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 1983
Decision Date May 18, 1983
Days to Decision 30 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
100d faster than avg
Panel avg: 130d · This submission: 30d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LIL Monitor, Penile Tumescence
Device Class -