Cleared Traditional

K870983 - NOCTURNAL PENILE TUMESCENCE MONITOR

K870983 · Texas Medical Electronics Co. · Gastroenterology & Urology device
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Jun 1987
Decision
105d
Days
-
Risk

K870983 is an FDA 510(k) clearance for the NOCTURNAL PENILE TUMESCENCE MONITOR. Classified as Monitor, Penile Tumescence (product code LIL).

Submitted by Texas Medical Electronics Co. (Houston, US). The FDA issued a Cleared decision on June 23, 1987 after a review of 105 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K870983

510(k) Number K870983 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 1987
Decision Date June 23, 1987
Days to Decision 105 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
26d faster than avg
Panel avg: 131d · This submission: 105d
Pathway characteristics
Predicate-based equivalence.

LIL Device Classification - Class 0,

Product Code LIL Monitor, Penile Tumescence
Device Class -

Regulatory Peers - LIL Monitor, Penile Tumescence

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