Skip to content

Carescape B850 E-musb

by GE Healthcare Finland Oy

510(k) K213336

Active European Union and United States

CE MDR 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) K213336↗

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 NumberK213336 Date13 Apr 2022ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K213336 decided 13 Apr 2022 Active
  • EUDAMED Active

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-2170-2024 FDA Class II initiated 5 Apr 2024

    GE HealthCare has become aware of the potential for loss of monitoring on CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, and certain versions of CARESCAPE B850 and CARESCAPE B650 monitors if, following the replacement of the CPU timekeeper battery, a mains power loss occurs during active monitoring. In the unlikely event that this occurs, it can result in the displays or monitors not turning on, after the mains power is restored. This can result in a delay in recognizing changes in patient condition until a replacement monitor is connected.

Timeline

2 dated events

  1. Cleared FDA 510(k) K213336
  2. Recall initiated FDA recalls Z-2170-2024

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR 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

Cited by

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 B850 E-musb is a physiological patient monitor designed for continuous cardiac and respiratory monitoring, featuring arrhythmia detection and alarm capabilities. It falls under the classification of a monitor for patients with arrhythmia detection or alarms, providing real-time vital sign assessment in clinical settings.

This device is intended for use in hospital, critical care, and emergency environments, supplied as a reusable medical instrument. It complies with FDA 510(k) clearance (K213336) and MDR authorisation, adhering to regulatory standards for Class II devices under product code MHX. No specific sterility or MRI safety information is provided in the data.

Other devices from GE Healthcare Finland Oy

See all devices from GE Healthcare Finland Oy →