# K201642: Paragon Adult Maxi PMP Oxygenator with Tubing Pack

- Pathway: 510(k) (Traditional)
- Applicant: Chalice Medical, Ltd.
- Decided: Sep 18, 2020 after 93 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). 9 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 11 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.
- K771692: Tubing Sets, Cobe Laboratories, Inc. (1977) Summary page 4.

## Most influential descendants
- K231414: CMO8 Adult PMP Oxygenator with Tubing Pack (Model: CME40009) (2023), 0 descendants of its own

## 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. The Tubing Pack is intended for use in extracorporeal circulation during cardiopulmonary bypass procedures, lasting 6 hours or less.

Source page: https://510kreport.com/device/K201642
Methodology: https://510kreport.com/methodology