510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K831251Substantially Equivalent

Tumisensor 1524

Life-Tech Intl., Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K831251 is the FDA 510(k) clearance record for TUMISENSOR 1524, cleared for Life-Tech Intl., Inc. on under FDA product code LIL (Monitor, Penile Tumescence). FDA records list 68 510(k) clearances for Life-Tech Intl., Inc., from to . As of , FDA records show no recalls naming K831251.

Clearance record

Decision date
Received
(46 days to decision)
Product code
LIL Monitor, Penile Tumescence
Device class
Unclassified
Review panel
Unknown
Applicant
Life-Tech Intl., Inc. 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