# K963518: Cobe Optima XP Hollow Fiber Membrane Oxygenator

- Pathway: 510(k) (Traditional)
- Applicant: Cobe Cardiovascular, Inc.
- Decided: Dec 8, 1997 after 461 days
- Product code: DTZ (Oxygenator, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4350
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
20 later devices descend from it; 1 cites it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) COBE® Optima™ Hollow Fiber Membrane Oxygenator: named in the summary without a submission number

## Most influential descendants
- K991452: Cobe Optimin Hollow Fiber Membrane Oxygenator (1999), 19 descendants of its own
- K043323: D 905 Eos Hollow Fiber Oxygenator with Integrated Hardshell Venous/Cardiotomy Reservoir (2005), 17 descendants of its own
- K120185: Inspire 6F Hollow Fiber Oxygenator with Integrated Arterial Filter and Hardshell Venous/Cardiotomy Reservior (2012), 8 descendants of its own
- K180448: INSPIRE 6M Hollow Fiber Oxygenator; INSPIRE 6F M Hollow Fiber Oxygenator with Integrated Arterial Filter; INSPIRE 8M Hollow Fiber Oxygenator; INSPIRE 8F M Hollow Fiber Oxygenator with Integrated Arterial Filter (2018), 5 descendants of its own
- K150489: EOS PMP, EOS PMP Integrated (2015), 5 descendants of its own

## Recalls of this device
- Jun 26, 2006 · Not classified · Z-1426-06: Cooling and rewarming time is extended. Efficiency of the heat exchangers is reduced because many of the folds that are critical to heat exchange on the blood side of the units were blocked with a met
- Jun 26, 2006 · Not classified · Z-1423-06: Cooling and rewarming time is extended. Efficiency of the heat exchangers is reduced because many of the folds that are critical to heat exchange on the blood side of the units were blocked with a met

## Indications for use
The Optima XP™ is intended to be used in adult surgical procedures requiring extracorporeal gas exchange support and blood temperature control for periods of up to 6 hours.

Source page: https://510kreport.com/device/K963518
Methodology: https://510kreport.com/methodology