# K020899: Parapac 200 Medic, Model P200, & Parapac 200D Medic, Model P200D

- Pathway: 510(k) (Traditional)
- Applicant: Pneupac, Ltd.
- Decided: Dec 13, 2002 after 268 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: 1 generation back to K960515 (1996). 1 ancestor in all.
3 later devices descend from it; 2 cite 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)
- K960515: Parapac, Pneupac, Ltd. (1996) Summary page 1.
- (no number) paraPAC ‘medic’ model 2: named in the summary without a submission number
- (no number) paraPAC ‘medic’ model 2D: named in the summary without a submission number

## Most influential descendants
- 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

## Indications for use
The paraPAC 200 & 200D are pprtable, gas powered, time-cycled ventilators that are designed for emergency ventilation of patients who have respiratory distress or insufficiency.

Source page: https://510kreport.com/device/K020899
Methodology: https://510kreport.com/methodology
