# K862830: Models 2R and 3R Pneupac Ventilator/Resuscitator

- Pathway: 510(k) (Traditional)
- Applicant: Pneupac, Ltd.
- Decided: Oct 15, 1986 after 84 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.
11 later devices descend from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

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

## Most influential descendants
- K024344: Pneuton Ventilator (2003), 10 descendants of its own
- K043085: Modification to: Pneuton Ventilator (2004), 9 descendants of its own
- K080692: Macs Cpap System (2008), 7 descendants of its own
- K092085: Ispira Resuscitation Unit (2009), 4 descendants of its own
- K102649: Neopop Infant Resuscitator with Flow Meter (2011), 2 descendants of its own

Source page: https://510kreport.com/device/K862830
Methodology: https://510kreport.com/methodology