Cleared Traditional

K841879 - LFT - 212

K841879 · Medical Monitoring Systems, Inc. · Gastroenterology & Urology device
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Jul 1984
Decision
80d
Days
-
Risk

K841879 is an FDA 510(k) clearance for the LFT - 212. Classified as Monitor, Penile Tumescence (product code LIL).

Submitted by Medical Monitoring Systems, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 26, 1984 after a review of 80 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.

FDA 510(k) Submission Details - K841879

510(k) Number K841879 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 1984
Decision Date July 26, 1984
Days to Decision 80 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
51d faster than avg
Panel avg: 131d · This submission: 80d
Pathway characteristics
Predicate-based equivalence.

LIL Device Classification - Class 0,

Product Code LIL Monitor, Penile Tumescence
Device Class -

Regulatory Peers - LIL Monitor, Penile Tumescence

All 18
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