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Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM)

by Welch Allyn, Inc.

510(k) K241411

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

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 NumberK241411 Date20 Dec 2024ClearedStatusActive

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-1559-2025 FDA Class II initiated 24 Mar 2025

    There were customer reports of devices which experienced battery-related fires. The investigation found that the devices in question were utilizing third-party, after-market batteries that are not approved by Baxter.

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  • Withdrawn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

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