# K961290: Iup - Tip Trans, Iup - Proxi Trans

- Pathway: 510(k) (Traditional)
- Applicant: Scientific Device Manufacturer, LLC
- Decided: Oct 15, 1996 after 194 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) IntranPlus (Utah Medical): named in the summary without a submission number
- (no number) Fetal Monitoring Intrauterine Pressure Kit, #14099C (Hewlett Packard): named in the summary without a submission number
- (no number) Corometrics: named in the summary without a submission number

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

## Indications for use
The intrauterine pressure monitoring catheter (IUP) is for use on patients requiring intrapartum intrauterine monitoring, amniofusion, and sampling of amniotic fluid.

Source page: https://510kreport.com/device/K961290
Methodology: https://510kreport.com/methodology