# K964279: Softrans Intrauterine Pressure Catheter System (Iup 4000 Softrans Iupc)

- Pathway: 510(k) (Traditional)
- Applicant: Graphic Controls Corp.
- Decided: Jan 22, 1997 after 86 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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

## Most influential descendants
- K982565: Easy Trans Tip (1998), 0 descendants of its own

## Indications for use
Intended for use in measuring the intensity, duration, and frequency of uterine contractions during labor. Also, the catheter may be used for amnioinfusion of fluid into the uterus or to sample amniotic fluid.

Source page: https://510kreport.com/device/K964279
Methodology: https://510kreport.com/methodology