# K231414: CMO8 Adult PMP Oxygenator with Tubing Pack (Model: CME40009)

- Pathway: 510(k) (Traditional)
- Applicant: Chalice Medical, Ltd.
- Decided: Nov 1, 2023 after 169 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: 7 generations back to K922933 (1992). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201642: Paragon Adult Maxi PMP Oxygenator with Tubing Pack, Chalice Medical, Ltd. (2020) Summary page 4.
- K920774: MVR Collapsible Venous Reservoir Bag, Medtronic Vascular (1992) Summary page 4.

## Indications for use
The CMO8 Adult 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 CMO8 Adult 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/K231414
Methodology: https://510kreport.com/methodology