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AlertWatch: OR

by Alertwatch, LLC 2 variants

510(k) K130401

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK130401 Date7 Feb 2014ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
MHX
Device Class
Class II
Regulation
21 CFR Part 870.1025
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The AlertWatch: OR is a Physiological Monitor designed for patient arrhythmia detection and alarm notification, as classified under FDA’s Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms) category. It continuously monitors cardiac activity in perioperative settings, providing real-time alerts for abnormal rhythms to support timely clinical intervention.

Intended for use in operating rooms, the device is supplied as a reusable system with FDA 510(k) clearance under the Traditional pathway, classified as Class II. It integrates with existing infrastructure and is regulated under 21 CFR 870.1025, ensuring compliance with cardiovascular monitoring standards. No specific sterility or MRI safety data is provided in the regulatory submission.

Other devices from Alertwatch, Inc.

  • AlertWatch:OB

    Class II

  • AlertWatch: OR

    Class II

  • AlertWatch:AC

    Class II

Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the AlertWatch: OR used for?

    The AlertWatch: OR is a physiological monitor specifically designed for perioperative settings, such as operating rooms. It continuously monitors cardiac activity to detect abnormal rhythms in real-time, providing timely alerts to support clinical intervention during surgical procedures.

  • How is the AlertWatch: OR supplied and is it reusable?

    The AlertWatch: OR is supplied as a reusable system. This means it is intended for repeated use across multiple patients after proper cleaning, maintenance, and sterilization procedures, ensuring compliance with medical device reprocessing standards.

  • Is the AlertWatch: OR sterile upon delivery?

    The regulatory submission does not specify whether the AlertWatch: OR is provided sterile out-of-the-box. Reusable devices typically undergo sterilization between uses in clinical settings, so proper reprocessing protocols must be followed to ensure sterility before each use.

  • What regulatory pathway was used for FDA clearance?

    The AlertWatch: OR received FDA 510(k) clearance under the Traditional pathway, classified as a Class II device. This pathway confirms that the device is substantially equivalent to a legally marketed predicate device, ensuring it meets established safety and performance standards for cardiovascular monitoring.

  • Does the AlertWatch: OR integrate with existing hospital infrastructure?

    Yes, the AlertWatch: OR is designed to integrate with existing perioperative infrastructure. This compatibility allows seamless incorporation into current clinical workflows, reducing setup time and enhancing operational efficiency in operating rooms.