Cleared Traditional

BIOREM 3000 & 4000 (K833454) - FDA 510(k) Clearance

K833454 · Biorem · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1984
Decision
146d
Days
-
Risk

K833454 is an FDA 510(k) clearance for the BIOREM 3000 & 4000. Classified as Monitor, Penile Tumescence (product code LIL).

Submitted by Biorem (Mchenry, US). The FDA issued a Cleared decision on February 21, 1984 after a review of 146 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.

View all Biorem devices

Submission Details

510(k) Number K833454 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 1983
Decision Date February 21, 1984
Days to Decision 146 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
16d slower than avg
Panel avg: 130d · This submission: 146d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LIL Monitor, Penile Tumescence
Device Class -