# K121758: Cerner Fetalink+(VERSION1.0)

- Pathway: 510(k) (Traditional)
- Applicant: Cerner Corp.
- Decided: Oct 9, 2012 after 116 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: 1 generation back to K090269 (2009). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090269: Airstrip OB, Airstrip Technologies, LP (2009) Summary page 1.

## Indications for use
Cerner FetaLink+ is a software-only application intended for use on iOS mobile devices by obstetrical healthcare clinicians to view near real time the simultaneous measurement of fetal heart rate(s) and uterine contractions waveforms in one view. FetaLink+ transforms the ongoing measurements into a visual wave display which conveys the frequency, duration and relative strength of uterine contractions combined with the patient data of pregnant women in the antepartum and/or intrapartum phases of pregnancy.

Source page: https://510kreport.com/device/K121758
Methodology: https://510kreport.com/methodology