# K070247: Giraffe and Panda Bag and Mask Resuscitation System

- Pathway: 510(k) (Traditional)
- Applicant: Ohmeda Medical
- Decided: Apr 20, 2007 after 85 days
- Product code: BTM (Ventilator, Emergency, Manual (Resuscitator))
- Device class: 2
- Regulation: 21 CFR 868.5915
- 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). 6 ancestors in all.
4 later devices descend from it; 1 cites it directly.
4 of 11 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.
- 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
- K090697: Modification to: Giraffe and Panda Warmer (2009), 1 descendant of its own
- K123309: Giraffe and Panda Warmers (2013), 0 descendants of its own

## Recalls of this device
- May 8, 2026 · Class I · Z-2357-2026: Blender knob shaft can loosen, which can affect the delivered oxygen concentration. The system can deliver an oxygen concentration that does not match the intended concentration set by the user, poten
- Dec 12, 2013 · Class II · Z-0915-2014: 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-0914-2014: 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-1071-2014: Oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed during assembly.
- Oct 15, 2012 · Class I · Z-0749-2013: Oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed during assembly.

## Indications for use
The Bag and Mask 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 (AHA) and the American Academy of Pediatrics (AAP) in the Textbook of Neonatal Resuscitation, 5th Edition.

Source page: https://510kreport.com/device/K070247
Methodology: https://510kreport.com/methodology