# K974812: Cobe (R) CML Duo (R) with Smart (TM) Surface Modified Membrance Oxygenator

- Pathway: 510(k) (Traditional)
- Applicant: Cobe Cardiovascular, Inc.
- Decided: Jun 1, 1998 after 160 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.
No later device cites it as a predicate yet.
0 of 1 device 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® CML Duo® Membrane Oxygenator: named in the summary without a submission number

## Recalls of this device
- Jun 26, 2006 · Not classified · Z-1425-06: 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-1422-06: 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 COBE® CML Duo® With SMAR, T™ Surface Modified Membrane Oxygenator is intended to be used in adult surgical procedures requiring extracorporeal gas exchange support and blood temperature control for periods of up to six hours.

Source page: https://510kreport.com/device/K974812
Methodology: https://510kreport.com/methodology