# K191246: Paragon Adult Maxi PMP Oxygenator (Model: XCMOP405PMP)

- Pathway: 510(k) (Traditional)
- Applicant: Chalice Medical, Ltd.
- Decided: Feb 28, 2020 after 295 days
- Product code: DTZ (Oxygenator, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4350
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K922933 (1992). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122254: Inspire 8 Hollow Fiber Oxygenator with Integrated Hardshell Venous/Cardiotomy Reservoir, Sorin Group Italia S.R.L. (2012) Summary page 4.

## Indications for use
The Paragon Adult Maxi PMP oxygenator is a hollow fiber membrane oxygenator intended for physiologic gas exchange in adults and small adults undergoing cardiopulmonary bypass surgery. The integrated heat exchanger makes it possible to regulate the blood temperature. The Paragon Adult Maxi PMP Oxygenator is intended for clinical use for up to 6 hours.

Source page: https://510kreport.com/device/K191246
Methodology: https://510kreport.com/methodology