510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K922323Substantially Equivalent

Mx4042/mc4044 Series Simulcath(tm)

Medex, Inc., Hilliard OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K922323 is the FDA 510(k) clearance record for MX4042/MC4044 SERIES SIMULCATH(TM), a class II device, cleared for Medex, Inc. on under FDA product code KXO (Monitor, Pressure, Intrauterine). FDA records list 20 510(k) clearances for Medex, Inc., from to . As of , FDA records show no recalls naming K922323.

Clearance record

Decision date
Received
(771 days to decision)
Product code
KXO Monitor, Pressure, Intrauterine
Regulation
21 CFR 884.2700
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Medex, Inc. 3637 Lacon Rd., Hilliard OH
510(k) summary
Statement
Third party review
No

Clearances, product code KXO

Trailing 12 months

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

FDA records show no clearances under product code KXO in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KXO, 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