# K130401: Alertwatch: or

- Pathway: 510(k) (Traditional)
- Applicant: Alertwatch, LLC
- Decided: Feb 7, 2014 after 353 days
- Product code: MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 27 generations back to K941811 (1994). 172 ancestors in all.
8 later devices descend from it; 2 cite it directly.
0 of 181 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082583: Intellivue Patient Monitor, Intellibridge Module, Models MP40, MP50, MP60, MP70, MP80, MP90, EC10, EC5, Philips Medizinsysteme Boeblingen GmbH, Cardiac AN (2009) Summary page 5.

## Most influential descendants
- K142106: Decisio Health Patient Dashboard (2015), 5 descendants of its own
- K213335: Capsule Surveillance System (2022), 3 descendants of its own
- K153335: AlertWatch: OR (2016), 1 descendant of its own
- K241958: WARD-CSS (v1.2.x) (2025), 0 descendants of its own
- K240756: Aitrics-VC (2024), 0 descendants of its own

## Indications for use
AlertWatch:OR is intended for use by clinicians for secondary monitoring of patients within operating rooms. AlertWatch:OR combines data from networked physiologic monitors, anesthesia information management systems and patient medical records and displays them in one place. AlertWatch:OR can only be used with both physiological monitors and AIMS versions that have been validated by AlertWatch. Once alerted, you must refer to the primary monitor or device before making a clinical decision.

Source page: https://510kreport.com/device/K130401
Methodology: https://510kreport.com/methodology