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AM12 41000-032-54

by Mortara Instrument, Inc.

AM12 41000-032-54 is a Class II device made by Mortara Instrument, Inc., cleared under FDA 510(k) K100127 on 16 Apr 2010 and listed in FDA GUDID since 19 Sep 2017 (UDI-DI 00817655022048), active as of 22 Oct 2026. One FDA recall is linked to it.

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) K100127

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 Number00817655022048 UDI-DI Date19 Sep 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Abbreviated NumberK100127 Date16 Apr 2010DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K100127 decided 16 Apr 2010 Active
  • FDA GUDID UDI-DI 00817655022048 listed 19 Sep 2017 Listed

Recalls

1 recall · FDA

    • Terminated Z-1810-2020 FDA Class II initiated 18 Mar 2020

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

Timeline

3 dated events

  1. Cleared FDA 510(k) K100127
  2. Listed FDA GUDID 00817655022048
  3. Recall initiated FDA recalls Z-1810-2020

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
AM12
Generic name
Electrocardiographic lead set, reusable
Model / reference
41000-032-54
Primary DI / UDI-DI
00817655022048
510(k) Number
FDA product code
DPS
GMDN term
Electrocardiographic lead set, reusable
Device class
Class II
Regulation number
870.2340
GUDID distribution status
In Commercial Distribution

Related devices

Category: Electrocardiographic lead set, reusable

Cleared under the same submission (K100127)

and 8 more cleared under K100127

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
  • Serial number
Other properties (13, all answered No)