510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K833454Substantially Equivalent

Biorem 3000 & 4000

Biorem, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K833454 is the FDA 510(k) clearance record for BIOREM 3000 & 4000, cleared for Biorem on under FDA product code LIL (Monitor, Penile Tumescence). FDA records list 2 510(k) clearances for Biorem, from to . As of , FDA records show no recalls naming K833454.

Clearance record

Decision date
Received
(146 days to decision)
Product code
LIL Monitor, Penile Tumescence
Device class
Unclassified
Review panel
Unknown
Applicant
Biorem 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code LIL

Trailing 12 months

FDA records hold no clearances under product code LIL in the trailing twelve months.

FDA records show no clearances under product code LIL in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LIL, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260