510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K870983Substantially Equivalent

Nocturnal Penile Tumescence Monitor

Texas Medical Electronics Co., Houston TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K870983 is the FDA 510(k) clearance record for NOCTURNAL PENILE TUMESCENCE MONITOR, cleared for Texas Medical Electronics Co. on under FDA product code LIL (Monitor, Penile Tumescence). FDA records list one 510(k) clearance for Texas Medical Electronics Co. As of , FDA records show no recalls naming K870983.

Clearance record

Decision date
Received
(105 days to decision)
Product code
LIL Monitor, Penile Tumescence
Device class
Unclassified
Review panel
Unknown
Applicant
Texas Medical Electronics Co. P.O. Box 35725, Houston TX
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