# K233440: Avalon CL Fetal & Maternal (F&M) Pod (866488), Avalon CL Fetal & Maternal (F&M) Patch (989803196341)

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medizin Systeme Boeblingen GmbH
- Decided: Jul 2, 2024 after 258 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: 6 generations back to K894277 (1989). 19 ancestors in all.
No later device cites it as a predicate yet.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140862: Monica Novii Wireless Patch System, Monica Healthcare, Ltd. (2014) Summary page 6.

## Indications for use
The Avalon CL Fetal & Maternal (F&M) Pod & Patch is a device indicated for use by healthcare professionals in a clinical setting for non-invasive monitoring of maternal heart rate (aHR), fetal heart rate (aFHR), and uterine activity (aToco) in women who are at >36 completed weeks, in labor, with singleton pregnancy, using surface electrodes on the maternal abdomen.

Source page: https://510kreport.com/device/K233440
Methodology: https://510kreport.com/methodology