# K043495: Babypac

- Pathway: 510(k) (Traditional)
- Applicant: Smiths Medical International Ltd., Luton
- Decided: Apr 22, 2005 after 126 days
- Product code: BTL (Ventilator, Emergency, Powered (Resuscitator))
- Device class: 2
- Regulation: 21 CFR 868.5925
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K960515 (1996). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970158: Babypac, Pneupac, Inc. (1998) Summary page 2.
- K020899: Parapac 200 Medic, Model P200, & Parapac 200D Medic, Model P200D, Pneupac, Ltd. (2002) Summary page 4.

## Most influential descendants
- K121379: Pneuton Mini Ventilator Pneuton Mini Non-Invasive Ventilation (Niv) Kit Accessory (2012), 0 descendants of its own

## Indications for use
The babyPAC 100 is a portable gas powered transport ventilator, suitable for use in an MRI environment up to 3 Tesla, which features a battery powered integrated electronic pressure alarm unit. It is designed for use by qualified medical caregivers, paramedics and other trained personnel, for ambulance, hospital, emergency and transport ventilation of patients during respiratory distress or insufficiency. It can be used on neonates and infants up to a bodyweight of 44lb (20 kg).

Source page: https://510kreport.com/device/K043495
Methodology: https://510kreport.com/methodology