Cleared Traditional

PENILE ERECTION MONITOR (K810944) - FDA 510(k) Clearance

K810944 · Medical Monitoring Systems, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1981
Decision
16d
Days
-
Risk

K810944 is an FDA 510(k) clearance for the PENILE ERECTION MONITOR. Classified as Monitor, Penile Tumescence (product code LIL).

Submitted by Medical Monitoring Systems, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 23, 1981 after a review of 16 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 Medical Monitoring Systems, Inc. devices

Submission Details

510(k) Number K810944 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 1981
Decision Date April 23, 1981
Days to Decision 16 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
114d faster than avg
Panel avg: 130d · This submission: 16d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LIL Monitor, Penile Tumescence
Device Class -