# K991452: Cobe Optimin Hollow Fiber Membrane Oxygenator

- Pathway: 510(k) (Traditional)
- Applicant: Cobe Cardiovascular, Inc.
- Decided: Oct 7, 1999 after 164 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
Longest line of descent: 1 generation back to K960074 (1996). 2 ancestors in all.
19 later devices descend from it; 2 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963518: Cobe Optima XP Hollow Fiber Membrane Oxygenator, Cobe Cardiovascular, Inc. (1997) Summary page 2.
- K960074: Capiox SX10 Hollow Fiber Oxygenator with Detachable Hardshell Venous Reservoir, Terumo Medical Corp. (1996) Summary page 2.

## Most influential descendants
- 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
- K203424: Quantum Perfusion Blood Oxygenator ECC VT200-E1, Quantum Perfusion Blood Oxygenator ECC VT200-E2, Quantum Perfusion Blood Oxygenator ECC VT160-E1,  Quantum Perfusion Blood Oxygenator ECC VT160-E2 (2021), 1 descendant of its own

## Recalls of this device
- Jun 26, 2006 · Not classified · Z-1424-06: 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-1427-06: 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® Optimin™ Hollow Fiber Membrane Oxygenator is intended to be used in surgical procedures requiring extracorporeal gas exchange support and blood temperature control. It is intended to be used in procedures requiring a maximum blood flow rate of 5 liters/min and lasting up to six hours.

Source page: https://510kreport.com/device/K991452
Methodology: https://510kreport.com/methodology