# K070210: Giraffe and Panda  T- Piece Resuscitation System

- Pathway: 510(k) (Traditional)
- Applicant: Ohmeda Medical
- Decided: Apr 20, 2007 after 88 days
- Product code: BTL (Ventilator, Emergency, Powered (Resuscitator))
- Device class: 2
- Regulation: 21 CFR 868.5925
- Recalls of this device: 5 (3 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K760102 (1976). 7 ancestors in all.
10 later devices descend from it; 5 cite it directly.
5 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971243: Ohmeda Infant Resuscitation System, Ohmeda Medical (1997) Summary page 1.
- K892885: Resubmitted RD1000 Neopuff Infant Resuscitator, Fisher & Paykel Electronics, Ltd. (1989) Summary page 1.
- K003335: Resuscitaire Radiant Warmer; Resuscitaire Birthing Room Warmer; Resuscitair Wall Mounted Radiant Warmer, Hill-Rom Air-Shields (2000) Summary page 1.
- K002355: Atom Infa Warmer V-505, Atom Medical Corp (2000) Summary page 1.

## Most influential descendants
- K070377: Giraffe and Panda Warmer (2007), 3 descendants of its own
- K072157: Modification to Giraffe and Panda Warmers (Giraffe and Panda Uninterruptible Power Supply) (2007), 2 descendants of its own
- K140707: Lifeborne Infant Resuscitator (2014), 1 descendant of its own
- K093913: Mercury Medical T-Piece Resuscitator (2010), 1 descendant of its own
- K090697: Modification to: Giraffe and Panda Warmer (2009), 1 descendant of its own

## Recalls of this device
- Dec 12, 2013 · Class II · Z-0917-2014: Medical device adjustment knob may be loose and affect the accuracy of blended Air/Oxygen gas mixture to patients.
- Dec 12, 2013 · Class II · Z-0916-2014: Medical device adjustment knob may be loose and affect the accuracy of blended Air/Oxygen gas mixture to patients.
- Oct 1, 2013 · Class I · Z-1070-2014: Oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed during assembly.
- Oct 15, 2012 · Class I · Z-0748-2013: Oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed during assembly.
- Jun 26, 2012 · Class I · Z-0606-2013: Disposable T-Piece circuits used with resuscitation systems are unable to achieve maximum Peak Inspiratory Pressure (PIP) during the pre-use check out procedure.

## Indications for use
The T-piece Resuscitation System provides the basic equipment required for pulmonary resuscitation of infants. Pulmonary resuscitation includes practices necessary to establish a clear airway and provide oxygen or air/oxygen mixtures and/or manual ventilation to the infant. These are clinical practices that represent the established standard of care.* Resuscitation may be required whenever an infant fails to establish effective, adequate breathing patterns necessary to meet tissue oxygen demands and/or to rid the body of carbon dioxide. For professional use only, by trained clinicians. * As stated in collaborative guidelines written by the American Heart Association (ARA) and the American Academy of Pediatrics (AAP) in the Textbook of Neonatal Resuscitation, 5a Edition.

Source page: https://510kreport.com/device/K070210
Methodology: https://510kreport.com/methodology