# K241882: Fetal & Maternal Monitor (F15A, F15A Air)

- Pathway: 510(k) (Traditional)
- Applicant: Edan Instruments, Inc.
- Decided: Aug 27, 2025 after 425 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: 33 generations back to K941811 (1994). 255 ancestors in all.
No later device cites it as a predicate yet.
1 of 256 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173042: Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Express; Fetal Monitor: Models F2, F3, Edan Instruments, Inc. (2018) Summary page 5.

## Indications for use
Fetal & Maternal Monitor (Model: F15A, F15A Air) is intended for providing Non-Stress testing or fetal monitoring for pregnant women from the 28th week of gestation. It is intended to be used only by trained and qualified personnel in antepartum examination rooms, labor and delivery rooms. Fetal & Maternal Monitor (Model: Fl5A, F15A Air) is intended for real time monitoring of fetal and maternal physiological parameters, including non-invasive monitoring and invasive monitoring: Non-invasive physiological parameters: * Maternal heart rates (MHR) * Maternal ECG (MECG) * Maternal temperature (TEMP) * Maternal oxygen saturation (SpO2) and pulse rates (PR) * Fetal heart rates (FHR) * Fetal movements (FM) * FTS-3 Note: SpO2 and PR are not available in Fl5A Air. Invasive physiological parameters: * Uterine activity * Direct ECG (DECG)

Source page: https://510kreport.com/device/K241882
Methodology: https://510kreport.com/methodology