# K863902: Modified Sarns Membrane Oxygenator

- Pathway: 510(k) (Traditional)
- Applicant: 3M Health Care, Sarns
- Decided: Dec 11, 1986 after 65 days
- Product code: DTX (Gas Control Unit, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 later devices descend from it; 1 cites it directly.
0 of 6 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
- K023745: Sechrist Air/Oxygen Mixer, Model 3500 CP-G (2003), 4 descendants of its own
- K101046: Stockert S5 System and Gas Blender and Sorin C5 System (2010), 3 descendants of its own
- K181942: Quantum Ventilation Module (2018), 2 descendants of its own
- K202733: Quantum Ventilation Module (2020), 1 descendant of its own
- K210669: Quantum Mini Ventilation Module (2021), 0 descendants of its own

Source page: https://510kreport.com/device/K863902
Methodology: https://510kreport.com/methodology