# K102140: Fetal Monitors, Models F2 and F3

- Pathway: 510(k) (Traditional)
- Applicant: Edan Instruments, Inc.
- Decided: Jan 13, 2011 after 168 days
- Product code: HGM (System, Monitoring, Perinatal)
- Device class: 2
- Regulation: 21 CFR 884.2740
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K852608 (1985). 7 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082369: Cadence, Cadence Dual, Cadence II Fetal Monitor, Edan Instruments, Inc. (2008) Summary page 1.

## Most influential descendants
- K173042: Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Express; Fetal Monitor: Models F2, F3 (2018), 1 descendant of its own
- K241882: Fetal & Maternal Monitor (F15A, F15A Air) (2025), 0 descendants of its own
- K141194: FM-3000 Fetal Monitor (2014), 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.

## Indications for use
The F2 and F3 Fetal Monitor are intended for non-invasive and invasive monitoring of fetus during antepartum examination, labor and delivery. They are intended to be used only by trained and qualified personnel in antepartum examination rooms, labor and delivery rooms. They both provide Non-stress testing for pregnant women from the 28th week of gestation. They can externally monitor the FHRs using ultrasound and uterine activity via a TOCO transducer. - Alternatively, they can internally monitor one of the FHRs with DECG and uterine activity with an [UPC.

Source page: https://510kreport.com/device/K102140
Methodology: https://510kreport.com/methodology