Giraffe and Panda Warmer

510(k) K070377

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

7 closed

Documents

FDA record

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

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK070377	Date11 Jul 2007Cleared	StatusActive

7 recalls · FDA

4 recalls, same reason
- Terminated Z-0482-2019 FDA Class II initiated 25 Sep 2018
- Terminated Z-0481-2019 FDA Class II initiated 25 Sep 2018
- Terminated Z-0483-2019 FDA Class II initiated 25 Sep 2018
- Terminated Z-0484-2019 FDA Class II initiated 25 Sep 2018
Potential electric leakage affecting the user.
- Terminated Z-1506-2017 FDA Class II initiated 18 Nov 2016
Certain power cords could overheat. The affected power cords were manufactured by Electric-Cord and are referred to as Taller Bridge power cords. The overheating of the power cord could result in fire, charring, smoke, or sparking where the power cord connects to the wall outlet which could cause thermal injury.
- Terminated Z-1072-2014 FDA Class I initiated 1 Oct 2013 on shared 510(k) K070377
Oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed during assembly.
- Terminated Z-2227-2008 FDA Unclassified (pre-2012) initiated 20 May 2008
Medical device software may be subject to signal interference of the Hands Free Alarm Silence feature that could impact patient safety.

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

1 jurisdiction

United States — FDA 510(k) Active

510(k)