# K173042: Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Express; Fetal Monitor: Models F2, F3

- Pathway: 510(k) (Traditional)
- Applicant: Edan Instruments, Inc.
- Decided: Aug 30, 2018 after 336 days
- Product code: HGM (System, Monitoring, Perinatal)
- Device class: 2
- Regulation: 21 CFR 884.2740
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 32 generations back to K941811 (1994). 254 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 256 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150901: Fetal & Maternal Monitor, models F6, F6 Express, F9, F9 Express, Edan Instruments, Inc. (2015) Summary page 5.
- K102140: Fetal Monitors, Models F2 and F3, Edan Instruments, Inc. (2011) Summary page 5.
- K152552: Patient Monitor, Edan Instruments, Inc. (2016) Summary page 5.

## Most influential descendants
- K241882: Fetal & Maternal Monitor (F15A, F15A Air) (2025), 0 descendants of its own

## Recalls of this device
- Oct 24, 2025 · Class II · Z-1140-2026: As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.
- Oct 24, 2025 · Class II · Z-1141-2026: As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.

## Indications for use
F6/F9 Fetal & Maternal Monitor is intended for non-invasive and invasive monitoring of fetus during antepartum examination, labor and delivery. It is intended to be used only by trained and qualified personnel in antepartum examination rooms, labor and delivery rooms. F6/F9 Fetal & Maternal Monitor provides Non-Stress testing for pregnant women from the 28th week of gestation. It can externally monitor the FHRs using ultrasound and uterine activity via a TOCO transducer. Alternatively, it can internally monitor one of the FHRs with DECG and uterine activity with an IUPC. F6 Express/F9 Express Fetal & Maternal Monitor is intended for monitoring physiological parameters of pregnant women during antepartum examination, labor and delivery. It is intended to be used only by trained and qualified personnel in antepartum examination rooms, labor and delivery rooms. F6 Express/F9 Express Fetal & Maternal Monitor is intended for providing Non-Stress testing or fetal monitoring for pregnant women from the 28th week of gestation. In addition, it provides a solution for maternal vital signs monitoring. F3/F2 Fetal Monitor is intended for non-invasive and invasive monitoring of fetus during antepartum examination, labor and delivery. It is intended to be used only by trained and qualified personnel in antepartum examination rooms, labor and delivery rooms. The monitor provides non-stress testing for pregnant women from the 28th week of gestation. It can externally monitor the FHRs using ultrasound and uterine activity via a TOCO transducer. Alternatively, it can internally monitor one of the FHRs with DECG and uterine activity with an IUPC.

Source page: https://510kreport.com/device/K173042
Methodology: https://510kreport.com/methodology