# K974389: Koala Intrauterine Pressure Catheter, Koala External Intrauterine Pressure Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Clinical Innovations, Inc.
- Decided: Feb 19, 1998 after 90 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
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) Medex MX 4041 Intrauterine Pressure Catheter: named in the summary without a submission number
- (no number) Graphic Controls Life Trace 3000 Intrauterine Pressure Catheter System: named in the summary without a submission number
- (no number) Utah Medical Products Intran Plus IUP Catheter: named in the summary without a submission number

## Most influential descendants
- K250897: Koala Intrauterine Pressure Catheter (IPC-5000E) (2025), 0 descendants of its own

## Indications for use
This catheter is for use on patients requiring intrapartum, intrauterine pressure monitoring.

Source page: https://510kreport.com/device/K974389
Methodology: https://510kreport.com/methodology