Cleared Traditional

DIGITAL INFLECTION RIGIDOMETER (DIR) (K000194) - FDA 510(k) Clearance

K000194 · Uroan Xxi Electromedicina · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2000
Decision
80d
Days
-
Risk

K000194 is an FDA 510(k) clearance for the DIGITAL INFLECTION RIGIDOMETER (DIR). Classified as Monitor, Penile Tumescence (product code LIL).

Submitted by Uroan Xxi Electromedicina (Baleares, ES). The FDA issued a Cleared decision on April 10, 2000 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.

View all Uroan Xxi Electromedicina devices

Submission Details

510(k) Number K000194 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 2000
Decision Date April 10, 2000
Days to Decision 80 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 130d · This submission: 80d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LIL Monitor, Penile Tumescence
Device Class -