# K910938: Codman External Drainage System II (Eds II)

- Pathway: 510(k) (Traditional)
- Applicant: Codman & Shurtleff, Inc.
- Decided: Aug 16, 1991 after 163 days
- Product code: JXG (Shunt, Central Nervous System And Components)
- Device class: 2
- Regulation: 21 CFR 882.5550
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
20 later devices descend from it; 3 cite it directly.
2 of 21 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
- K984053: Becker External Drainage and Monitoring System (1999), 13 descendants of its own
- K171880: IRRAflow CNS System (2018), 4 descendants of its own
- K161605: Smart External Drain (SED) System (2016), 4 descendants of its own
- K061568: Codman Eds 3 CSF External Drainage System, Models 82-1730, 82-1731, 82-1732, 82-1733, 82-1735, 82-1738 (2006), 4 descendants of its own
- K192289: IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit (2019), 3 descendants of its own

Source page: https://510kreport.com/device/K910938
Methodology: https://510kreport.com/methodology