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CARESCAPE B450 E-musb

by GE Healthcare Finland Oy

510(k) K213363

Active European Union and United States

CE MDR CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K213363↗

FDA record

Trust

Unverified

Source EUDAMED, FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK213363 Date13 Apr 2022ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive
European UnionCE/MDD EUDAMED Number— Date—StatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K213363 decided 13 Apr 2022 Active
  • EUDAMED Active· +1 more in the status table

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-0453-2026 FDA Class II initiated 26 Sep 2025

    Potential loss of monitoring on affected monitors when powered by certain batteries. Affected batteries can lose capability to hold charge and provide back up power. If this situation occurs, it will cause loss of patient monitoring and potentially delay recognizing patient status changes requiring treatment.

Timeline

2 dated events

  1. Cleared FDA 510(k) K213363
  2. Recall initiated FDA recalls Z-0453-2026

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR, CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 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

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 18 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 Carescape B450 E-musb is a physiological patient monitor designed for continuous, non-invasive monitoring of vital signs. It detects and alerts for arrhythmias, providing real-time cardiac rhythm analysis and alarm capabilities for clinical decision support in cardiovascular care.

This device is intended for use in hospital, critical care, and clinical settings, supplied as a reusable medical instrument. It is classified as Class II under FDA regulations and complies with MDD and MDR directives. The monitor operates with standard electrical connectivity and is not intended for MRI environments. Storage and maintenance follow manufacturer guidelines to ensure proper functionality and sterility.

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