# K140163: Koala Toco

- Pathway: 510(k) (Traditional)
- Applicant: Clinical Innovations, LLC
- Decided: May 29, 2014 after 127 days
- Product code: HFM (Monitor, Uterine Contraction, External (For Use In Clinic))
- Device class: 2
- Regulation: 21 CFR 884.2720
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K843385 (1984). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013477: Toco Lite, Model TD-01, Ventrex, Inc. (2002) Summary page 1.

## Indications for use
The single-use disposable, non-sterile Koala TOCO is intended for use in conjunction with standard fetal monitors for the evaluation of relative external uterine activity during antepartum and intrapartum periods in a clinical setting. The Koala IUP/TOCO Reusable Cable is also for use with the Koala Intrauterine Pressure Catheter for intrapartum, intrauterine pressure monitoring. The Koala TOCO and Koala IUP/TOCO Reusable Cable are not intended for home monitoring of pre-term labor.

Source page: https://510kreport.com/device/K140163
Methodology: https://510kreport.com/methodology