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H12+ Patient Cable 9293-028-50

by Mortara Instrument, Inc.

H12+ Patient Cable 9293-028-50 is a Class II device made by Mortara Instrument, Inc., cleared under FDA 510(k) K050896 on 24 Aug 2005 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00812345023060), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

510(k) K050896

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00812345023060 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK050896 Date24 Aug 2005DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K050896 decided 24 Aug 2005 Active
  • FDA GUDID UDI-DI 00812345023060 listed 24 Sep 2016 Listed

Recalls

1 recall · FDA

    • Terminated Z-1812-2020 FDA Class II initiated 18 Mar 2020 on shared 510(k) K050896

    Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment.

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

Timeline

3 dated events

  1. Cleared FDA 510(k) K050896
  2. Listed FDA GUDID 00812345023060
  3. Recall initiated FDA recalls Z-1812-2020

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
H12+ Patient Cable
Generic name
Electrocardiographic lead set, reusable
Model / reference
9293-028-50
Primary DI / UDI-DI
00812345023060
510(k) Number
FDA product code
DSH
GMDN term
Electrocardiographic lead set, reusable
Device class
Class II
Regulation number
870.2800
GUDID distribution status
In Commercial Distribution

Related devices

Category: Electrocardiographic lead set, reusable

Cleared under the same submission (K050896)

and 1 more cleared under K050896

Similar devices in this category

Other devices filed under Electrocardiographic lead set, reusable.

Other devices from Mortara Instrument, Inc.

See all devices from Mortara Instrument, Inc. →

Properties

  • Prescription use
  • Lot / batch number
Other properties (13, all answered No)