FDA 510(k) · Alertwatch
K153335: AlertWatch: OR (Alertwatch, LLC)
Alertwatch, LLC received FDA 510(k) K153335 for AlertWatch: OR, with a decision date of Mar 15, 2016 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K153335 |
|---|---|
| Pathway | 510(k) |
| Applicant | Alertwatch, LLC |
| Device name | AlertWatch: OR |
| Product code | MWI: Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) |
| Regulation (21 CFR) | 870.2300 |
| Device class | Class 2 |
| Date received | Nov 19, 2015 |
| Decision date | Mar 15, 2016 |
| Decision | Substantially Equivalent (SESE) |
| 510(k) type | Traditional |
Source: openFDA device 510(k) data, data through Oct 26, 2026.
Indications for use parsed from FDA documents
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.
Extracted automatically from FDA's 510(k) summary. It can contain extraction errors and is not a verified quote. Read the wording in the FDA PDF before relying on it.
Predicates parsed from FDA documents
FDA numbers found next to the word "predicate" in the summary. The list can include reference devices; check the PDF for which device is the primary predicate.
ChatPPG interpretation
A 510(k) decision of "substantially equivalent" means FDA found the device as safe and effective as a legally marketed predicate. FDA's word for this is cleared, not approved. The clearance covers the device and indications in this submission; it does not extend to other features or versions of the same product that were not part of it. See FDA cleared vs approved.
Product code MWI is "Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)", class 2, 21 CFR 870.2300.
Our labels for filtering: claim Remote / vital-sign monitoring, sensor Wrist PPG. These are heuristics, not FDA fields.