# K023931: Philips Avalon CTS Cordless Fetal Transducer System, Models M2720A, M2725A, M2726A, M2727A

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems, Inc.
- Decided: Feb 24, 2003 after 90 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: 3 generations back to K894277 (1989). 12 ancestors in all.
76 later devices descend from it; 6 cite it directly.
0 of 89 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K942887: Model M1310A, Series 50T Fetal Telemetry System, Hewlett-Packard Co. (1994) Summary page 1.
- K900480: M1350A Fetal Monitor (Intrapartum), Hewlett-Packard Co. (1990) Summary page 1.
- K954351: Series 50XM, Hewlett-Packard GmbH (1996)
- K921957: Hewlett-Packard Model M1351A Fetal Monitor, Hewlett-Packard Co. (1993) Summary page 1.
- K921956: Hewlett Packard Model M1353A Fetal Monitor, Hewlett-Packard Co. (1993) Summary page 1.
- K993516: HP M2600A Viridia Telemetry System, Hewlett-Packard Co. (1999) Summary page 1.
- K980429: HP M2600A Viridia Telemetry System (Formerly Known as the HP 2600A Omni-Care Telemetry System), Hewlett-Packard Co. (1998) Summary page 1.

## Cited in the summary but kept off the family tree
- K961265: Philips M2600A Telemetry Systems. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1.

## Most influential descendants
- K100598: Penrith Elettra Ultrasound System (2010), 64 descendants of its own
- K151339: SONON Ultrasound Imaging System (Model: SONON 300C) (2015), 33 descendants of its own
- K162417: Acuson Freestyle Ultrasound System (2016), 29 descendants of its own
- K163138: Clarius Ultrasound System (2016), 28 descendants of its own
- K163396: ACUSON P500 Ultrasound System (2017), 27 descendants of its own

## Indications for use
The Philips Avalon CTS Cordless Fetal Transducer System (M2720A) and Accessories is indicated for pregnant women from about 22 weeks of gestation on through delivery. It is intended for continuous cordless fetal monitoring in connection with a fetal monitor for resting or ambulating patients, also usable during hydrotherapy, for antepartum testing and labor and delivery (intrapartum). The system should only be used by, or under the direct supervision of, a licensed physician or other health care practitioner who is trained in the use of fetal heart rate monitors and in the interpretation of fetal heart rate traces. It is not intended for home use.

Source page: https://510kreport.com/device/K023931
Methodology: https://510kreport.com/methodology