# K971243: Ohmeda Infant Resuscitation System

- Pathway: 510(k) (Traditional)
- Applicant: Ohmeda Medical
- Decided: Dec 2, 1997 after 243 days
- Product code: BTM (Ventilator, Emergency, Manual (Resuscitator))
- Device class: 2
- Regulation: 21 CFR 868.5915
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K760102 (1976). 3 ancestors in all.
12 later devices descend from it; 2 cite it directly.
6 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K760102: Flowmeter, P.C., Redesigned Version, Ohio Medical Products (1976) Summary page 1.
- K883229: Ohmeda Continuous Suction Regulator, Ohmeda Medical (1988) Summary page 1.
- K853905: Ohmeda Oxygen Blender, Ohmeda Medical (1985) Summary page 1.
- (no number) Air Shields Resuscitaire™ (resuscitation section / Radiant Warmer): named in the summary without a submission number
- (no number) Hill Rom Stabilet 2000C Infant Warmer (resuscitation section): named in the summary without a submission number

## Most influential descendants
- K070210: Giraffe and Panda  T- Piece Resuscitation System (2007), 10 descendants of its own
- K070247: Giraffe and Panda Bag and Mask Resuscitation System (2007), 4 descendants of its own
- 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

## Indications for use
The Infant Resuscitation System provides the basic equipment required for pulmonary resuscitation during infancy. Pulmonary resuscitation includes practices necessary to establish a clear airway and provide oxygen and/or manual ventilation to the infant. These practices are well-described in collaborative guidelines established by the American Heart Association (AHA) and the American Academy of Pediatrics (AAP). 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. The Infant Resuscitation System incorporates the following features for the practice of infant resuscitation: a suction device for routine clearance of the trachea and nasal passages; an oxygen flowmeter to deliver 100% oxygen to the infant requiring such therapy; and an airway pressure manometer with an adjustable pressure relief valve (12-55 cm H20). The airway pressure manometer may be attached to a resuscitation_bag (not included) and is used to measure the pressure being delivered to the infant in order to facilitate adequate pressurization of the lungs. An adjustable pressure relief valve is a safety feature which helps prevent the user from over-inflating the infant’s lungs, which could result in rupture of the alveoli. The valve may be adjusted to release excess gas at a user selected pressure point. The ability to adjust the pressure relief valve facilitates optimal oxygen delivery as-ling compliance changes dynamically after birth during the transition to extrauterine life. The operative range (12-55 cm H20) of this feature meets the recommendations by the AHA and AAP. The Infant Resuscitation System is outfitted with unregulated air and oxygen outlet connection which may be attached to an optional gas blender for the purposes of delivering air and oxygen mixes in the user selected percentages. The Resuscitation System may be equipped with optional hoses to connect the system to wall or cylinder outlets and/or yoke assemblies. The Infant Resuscitation System does not include the resuscitation bag for manual ventilation.

Source page: https://510kreport.com/device/K971243
Methodology: https://510kreport.com/methodology