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Cardio Clear H404

by Cardio-Medical Products, Inc.

Cardio Clear H404 is an external defibrillation electrode (FDA Class II; FDA product code LDD, Dc-Defibrillator, Low-Energy, (Including Paddles)) made by Cardio-Medical Products, Inc., cleared under FDA 510(k) K103159 on 11 Jan 2011 and listed in FDA GUDID since 28 Jul 2015 (UDI-DI 00814907020210), active as of 8 Nov 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) K103159

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 8 Nov 2026.

Regulatory status

as of registry sync 8 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00814907020210 UDI-DI Date28 Jul 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK103159 Date11 Jan 2011DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K103159 decided 11 Jan 2011 Active
  • FDA GUDID UDI-DI 00814907020210 listed 28 Jul 2015 Listed

Recalls

1 recall · FDA

    • Terminated Z-1669-2013 FDA Class II initiated 26 Apr 2013

    Covidien received customer reports of Arcing/Sparking on the defibrillation electrode leadwire which may affect Cardio Medical Products Inc. defibrillator electrodes Model Number O101.

Timeline

3 dated events

  1. Cleared FDA 510(k) K103159
  2. Recall initiated FDA recalls Z-1669-2013
  3. Listed FDA GUDID 00814907020210

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Cardio Clear
Generic name
External defibrillation electrode, adult, single-use
Model / Ref / Catalog
H404
Primary DI / UDI-DI
00814907020210
510(k) Number
FDA product code
LDD
GMDN term
External defibrillation electrode, adult, single-use
Device class
Class II
Regulation number
870.5300
GUDID distribution status
In Commercial Distribution

Related devices

Category: External defibrillation electrode, adult, single-use

Cleared under the same submission (K103159)

and 8 more cleared under K103159

Similar devices

Other devices filed under FDA product code LDD (Dc-Defibrillator, Low-Energy, (Including Paddles)).

Other devices from Cardio-Medical Products, Inc.

See all devices from Cardio-Medical Products, Inc. →

Properties

  • Single use
  • Lot / batch number
  • Expiration date
Other properties (12, all answered No)