# K173715: AlertWatch:OB

- Pathway: 510(k) (Traditional)
- Applicant: Alertwatch, Inc.
- Decided: Apr 23, 2018 after 140 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: 29 generations back to K941811 (1994). 174 ancestors in all.
No later device cites it as a predicate yet.
0 of 175 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153335: AlertWatch: OR, Alertwatch, LLC (2016) Summary page 4.

## Indications for use
AlertWatch:OB is intended for use by clinicians for secondary monitoring of maternal patients in the labor and delivery unit. AlertWatch:OB is a maternal surveillance system that combines data from validated electronic medical record systems, and displays them in one place. Once alerted by AlertWatch:OB, the clinician must refer to the primary monitor, device, or data source before making a clinical decision.

Source page: https://510kreport.com/device/K173715
Methodology: https://510kreport.com/methodology