# K103317: Resuscitation Unit 105

- Pathway: 510(k) (Traditional)
- Applicant: Atom Medical Corporation
- Decided: Apr 20, 2011 after 161 days
- Product code: BZR (Mixer, Breathing Gases, Anesthesia Inhalation)
- Device class: 2
- Regulation: 21 CFR 868.5330
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K760102 (1976). 12 ancestors in all.
No later device cites it as a predicate yet.
1 of 13 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060461: V-505 Infa Warmer, Atom Medical, Inc. (2006) Summary page 1.
- K925982: BMD Air/Oxygen Blender, Biomedical Devices, Inc. (1993) Summary page 1.
- K053232: Precision Blender, Precision Medical, Inc. (2006) Summary page 2.
- K070210: Giraffe and Panda  T- Piece Resuscitation System, Ohmeda Medical (2007) Summary page 1.

## Indications for use
The Resuscitation Unit 105 PV and Resuscitation Unit 105 EV are intended to remove secretions from the neonatal / infant airways and to provide blended air and oxygen at a desired oxygen concentration in the range of 21-100% to a respiratory assist device connected to the patient such as a ventilator (including a manually operated one) and an oxygen tent.

Source page: https://510kreport.com/device/K103317
Methodology: https://510kreport.com/methodology