# K960515: Parapac

- Pathway: 510(k) (Traditional)
- Applicant: Pneupac, Ltd.
- Decided: Oct 10, 1996 after 248 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
No predicates in its family tree.
4 later devices descend from it; 1 cites it directly.
1 of 5 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K020899: Parapac 200 Medic, Model P200, & Parapac 200D Medic, Model P200D (2002), 3 descendants of its own
- K043495: Babypac (2005), 1 descendant of its own
- K123957: Pneupac Parapac Plus (2013), 0 descendants of its own
- K121379: Pneuton Mini Ventilator Pneuton Mini Non-Invasive Ventilation (Niv) Kit Accessory (2012), 0 descendants of its own

Source page: https://510kreport.com/device/K960515
Methodology: https://510kreport.com/methodology