510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K991235Substantially Equivalent

Softrans Temp Intrauterine Pressure Catheter System (Iup 5000, Softrans Temp Iupc)

Ludlow Technical Products, Chicopee MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K991235 is the FDA 510(k) clearance record for SOFTRANS TEMP INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 5000, SOFTRANS TEMP IUPC), a class II device, cleared for Ludlow Technical Products on under FDA product code KXO (Monitor, Pressure, Intrauterine). FDA records list 5 510(k) clearances for Ludlow Technical Products, from to . As of , FDA records show no recalls naming K991235.

Clearance record

Decision date
Received
(87 days to decision)
Product code
KXO Monitor, Pressure, Intrauterine
Regulation
21 CFR 884.2700
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Ludlow Technical Products Two Ludlow Park, Chicopee MA
510(k) summary
Summary
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