Cleared Traditional

BIOREM 2000 (K822099) - FDA 510(k) Clearance

K822099 · Biorem · Gastroenterology & Urology device
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Aug 1982
Decision
42d
Days
-
Risk

K822099 is an FDA 510(k) clearance for the BIOREM 2000. Classified as Monitor, Penile Tumescence (product code LIL).

Submitted by Biorem (Mchenry, US). The FDA issued a Cleared decision on August 27, 1982 after a review of 42 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.

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Submission Details

510(k) Number K822099 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 1982
Decision Date August 27, 1982
Days to Decision 42 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
88d faster than avg
Panel avg: 130d · This submission: 42d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LIL Monitor, Penile Tumescence
Device Class -