# K974730: Softrans Plus Intrauterine Pressure Catheter System (Iup 5000, Softrans Plus Iupc)

- Pathway: 510(k) (Traditional)
- Applicant: Graphic Controls Corp.
- Decided: Jul 14, 1998 after 208 days
- Product code: KXO (Monitor, Pressure, Intrauterine)
- Device class: 2
- Regulation: 21 CFR 884.2700
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Softrans® Intrauterine Pressure Catheter System: named in the summary without a submission number
- (no number) Welch Allyn (DIATEK) SureTemp Thermometer System: named in the summary without a submission number

## Indications for use
The Softrans® Temp IUPC® may be used during the intrapartum period to monitor intrauterine pressure, to monitor intrauterine temperature, to amnioinfuse or to perform amniotic fluid sampling.

Source page: https://510kreport.com/device/K974730
Methodology: https://510kreport.com/methodology