Skip to content

AlertWatch: OR

by Alertwatch, LLC 2 variants

510(k) K153335

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 NumberK153335 Date15 Mar 2016ClearedStatusActive

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  • Withdrawn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
MWI
Device Class
Class II
Regulation
21 CFR Part 870.2300
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 Sep 2026

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

AlertWatch: OR is a medical device designed for monitoring in the operating room setting. It provides real-time tracking and analysis of patient vital signs during surgical procedures.

The device is supplied by Alertwatch, LLC and is intended for single-use in clinical environments. It is MRI safe and requires proper storage conditions as specified by the manufacturer. The device has received FDA 510(k) clearance with product code MWI and was reviewed by the Cardiovascular advisory committee.

Other devices from Alertwatch, Inc.

  • AlertWatch:OB

    Class II

  • AlertWatch: OR

    Class II

  • AlertWatch:AC

    Class II