# K250897: Koala Intrauterine Pressure Catheter (IPC-5000E)

- Pathway: 510(k) (Traditional)
- Applicant: Clinical Innovations, LLC
- Decided: May 22, 2025 after 58 days
- Product code: HFN (Transducer, 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 K974389 (1998). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974389: Koala Intrauterine Pressure Catheter, Koala External Intrauterine Pressure Catheter, Clinical Innovations, Inc. (1998) Summary page 5.

## Indications for use
Koala Intrauterine Pressure Catheter is indicated for use on patients requiring intrapartum intrauterine pressure monitoring.

Source page: https://510kreport.com/device/K250897
Methodology: https://510kreport.com/methodology