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Connex Spot Monitor, 901058 Vital Signs Monitor Core

by Welch Allyn, Inc.

510(k) K142356

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

3 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 NumberK142356 Date19 Dec 2014ClearedStatusActive

Recalls

3 recalls · 3 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-1565-2025 FDA Class II initiated 21 Mar 2025
    • Ongoing Z-1564-2025 FDA Class II initiated 21 Mar 2025 on shared 510(k) K142356

    Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.

    • Ongoing Z-2581-2023 FDA Class II initiated 10 Aug 2023

    Product is being recalled due to the improper placement of a copper tape on the back of the liquid-crystal display.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

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  • Withdrawn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

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