# K110556: Mini Telemetry System

- Pathway: 510(k) (Traditional)
- Applicant: Wipro GE Healthcare Private, Ltd.
- Decided: Jul 19, 2011 after 141 days
- Product code: HGM (System, Monitoring, Perinatal)
- Device class: 2
- Regulation: 21 CFR 884.2740
- 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 K910260 (1991). 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)
- K910260: Corometrics MDL 330 Fetal/Maternal Telemetry Syst, Ge Medical Systems Information Technologies (1991) Summary page 1.

## Indications for use
The Mini Telemetry system is intended to transmit fetal heart rate and uterine activity signals from an ambulatory mother to a fetal or maternal fetal monitor during the ante partum period and during labor. The system allows ultrasound fetal heart rate, FECG, MECG and uterine activity signals to be monitored individually or in combination. The Mini Telemetry system is intended for use under the direct supervision of a licensed healthcare practitioner in a defined coverage area. The Mini Telemetry device is not intended to be operated in mobile vehicles including ambulances or other vehicles associated with health care facilities.

Source page: https://510kreport.com/device/K110556
Methodology: https://510kreport.com/methodology