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Bedside Paediatric Early Warning System (BedsidePEWS)

by Bedside Clinical Systems, Inc.

510(k) K124038

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 NumberK124038 Date21 Jun 2013ClearedStatusActive

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  • Withdrawn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, 25 Sep 2026

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

The Bedside Paediatric Early Warning System (BedsidePEWS) is a clinical decision support tool designed to augment clinician expertise, objectively identify children at risk for clinical deterioration, and standardize and prioritize care to improve outcomes in community settings. It is a substantially equivalent device cleared through the FDA 510(k) process under product code MWI, with traditional clearance granted on June 21, 2013.

The device is supplied by Bedside Clinical Systems, Inc., located at 611 W. 5th St. Third Floor, Austin, TX 78701, US. It is intended for use in clinical settings to support early detection of patient deterioration in paediatric populations, with no claims made regarding sterility, single-use or reusable status, MRI safety, specific sizes, or storage conditions in the provided data.

Questions

AI-generated answers, 25 Sep 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 Bedside Paediatric Early Warning System (BedsidePEWS) used for?

    The BedsidePEWS is a clinical decision support tool designed to augment clinician expertise, objectively identify children at risk for clinical deterioration, and standardize and prioritize care to improve outcomes in community settings.

  • How is the BedsidePEWS supplied and by whom?

    The device is supplied by Bedside Clinical Systems, Inc., located at 611 W. 5th St. Third Floor, Austin, TX 78701, US.

  • Does the BedsidePEWS have any claims regarding sterility, single-use, or reusable status?

    No claims are made regarding sterility, single-use or reusable status for the BedsidePEWS in the provided device data.

  • What regulatory pathway was used for the BedsidePEWS clearance?

    The BedsidePEWS is a substantially equivalent device cleared through the FDA 510(k) process under product code MWI, with traditional clearance granted on June 21, 2013.