# K842908: Variable Prime Cobe Membrane Lung

- Pathway: 510(k) (Traditional)
- Applicant: Cobe Laboratories, Inc.
- Decided: Feb 1, 1985 after 192 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
No predicates in its family tree.
27 later devices descend from it; 1 cites it directly.
2 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K022115: Capiox RX05 Hollow Fiber Oxygenator W/Without Hardshell Reservoir (2002), 26 descendants of its own
- K062381: Capiox RX Oxygenator with or Without Reservoir (2006), 9 descendants of its own
- K130333: Capix RX Hollow Fiber Oxygenator with/Without Hardshell Reservoir (2013), 7 descendants of its own
- K102464: Quadrox-I Neonatal Microporous Membrane Oxygenator with Integrated Arterial Filter with Softline/Bioline Coating (2011), 6 descendants of its own
- K140774: Terumo Capiox FX15 and FX25 Hollow Fiber Oxygenator/Reservoir (2014), 5 descendants of its own

Source page: https://510kreport.com/device/K842908
Methodology: https://510kreport.com/methodology