# K923272: Cobe CMS-HF Hollow Fiber Membrane Oxygenator

- Pathway: 510(k) (Traditional)
- Applicant: Cobe Laboratories, Inc.
- Decided: May 11, 1993 after 309 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.
11 later devices descend from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K961530: Gish Reliance Oxygenator (Model Hfo) (1996), 10 descendants of its own
- K082403: Medos Hilite Oxygenator, Model 7000 & 7000 LT (2009), 6 descendants of its own
- K133261: Medos Hilite 7000 & 7000 LT Oxygenator (2014), 5 descendants of its own
- K191407: Novalung System (2020), 3 descendants of its own
- K023381: Vision Hollow Fiber Oxygenator with Guardian Coating (2003), 2 descendants of its own

Source page: https://510kreport.com/device/K923272
Methodology: https://510kreport.com/methodology