Cleared Traditional

K833454 - BIOREM 3000 & 4000

K833454 · Biorem · Gastroenterology & Urology device
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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.

FDA 510(k) Submission Details - K833454

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
15d slower than avg
Panel avg: 131d · This submission: 146d
Pathway characteristics
Predicate-based equivalence.

LIL Device Classification - Class 0,

Product Code LIL Monitor, Penile Tumescence
Device Class -

Regulatory Peers - LIL Monitor, Penile Tumescence

All 18
Devices cleared under the same product code (LIL) and FDA review panel - the closest regulatory comparables to K833454.
BARD (R) ESKA ERECTIOMETER
K880903 · C.R. Bard, Inc. · May 1988
SURGITEK NPT MONITOR
K875333 · Surgitek · Apr 1988
DACOMED RIGISCAN SYSTEM
K841202 · Dacomed Corp. · Jul 1984
DACOMED SNAP-GAUGE
K832121 · Dacomed Corp. · Jul 1983
TUMISENSOR 1524
K831251 · Life-Tech Intl., Inc. · Jun 1983
TUMISTORE RECORDER 1311
K831252 · Life-Tech Intl., Inc. · May 1983