# K223161: OXY-1 System

- Pathway: 510(k) (Traditional)
- Applicant: Abiomed, Inc.
- Decided: Feb 23, 2023 after 139 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 K932252 (1993). 18 ancestors in all.
No later device cites it as a predicate yet.
1 of 19 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200109: OXY-1 System, Abiomed, Inc. (2020) Summary page 4.

## Indications for use
The OXY-1 System is intended to be used for extracorporeal circulation. The OXY-1 System pumps, oxygenates and removes carbon dioxide from blood during cardiopulmonary bypass up to 6 hours in duration

Source page: https://510kreport.com/device/K223161
Methodology: https://510kreport.com/methodology