# K982565: Easy Trans Tip

- Pathway: 510(k) (Traditional)
- Applicant: Carl Schuh
- Decided: Sep 22, 1998 after 61 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
Longest line of descent: 1 generation back to K905563 (1991). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961290: Iup - Tip Trans, Iup - Proxi Trans, Scientific Device Manufacturer, LLC (1996) Summary page 1.
- K905563: Intran Plus, Utah Medical Products, Inc. (1991) Summary page 1.
- K955443: Intran Plus, Utah Medical Products, Inc. (1996) Summary page 1.
- K964279: Softrans Intrauterine Pressure Catheter System (Iup 4000 Softrans Iupc), Graphic Controls Corp. (1997) Summary page 1.
- (no number) Hewlett Packard: named in the summary without a submission number

## Indications for use
This intrauterine pressure monitoring catheter (IUPC) is for use on patients requiring intrapartum intrauterine pressure monitoring. Additionally it may be used for amniofusion and for amniotic fluid sampling.

Source page: https://510kreport.com/device/K982565
Methodology: https://510kreport.com/methodology