# K153335: AlertWatch: OR

- Pathway: 510(k) (Traditional)
- Applicant: Alertwatch, LLC
- Decided: Mar 15, 2016 after 117 days
- Product code: MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.2300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 28 generations back to K941811 (1994). 173 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 175 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130401: Alertwatch: or, Alertwatch, LLC (2014) Summary page 4.

## Most influential descendants
- K173715: AlertWatch:OB (2018), 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. AlertWatch:OR is also intended for use by supervising anesthesiologists outside of operating rooms. Once alerted, the supervising anesthesiologist must contact the clinician inside the operating room or must return to the operating room before making a clinical decision. Once either clinician is alerted, they must refer to the primary monitor or device before making a clinical decision.

Source page: https://510kreport.com/device/K153335
Methodology: https://510kreport.com/methodology