# K243676: Duet External Drainage and Monitoring System (EDMS)

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Neurosurgery
- Decided: Mar 10, 2025 after 103 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
Longest line of descent: 3 generations back to K902257 (1990). 4 ancestors in all.
No later device cites it as a predicate yet.
2 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200456: Becker External Drainage and Monitoring System, Medtronic, Inc. (2020) Summary page 5.

## Indications for use
The Duet EDMS is indicated for draining and monitoring of CSF flow from the lateral ventricles or lumbar subarachnoid space in selected patients to: • Reduce intracranial pressure (ICP), e.g., pre-, intra- or postoperative. • Monitor CSF chemistry, cytology, and physiology. • Provide temporary CSF drainage in patients with infected cerebrospinal fluid shunts. Monitoring of intracranial pressure (ICP) is indicated in selected patients with: • Severe head injury • Subarachnoid hemorrhage graded III, IV, or V preoperatively • Reyes syndrome or similar encephalopathies • Hydrocephalus • Intracranial hemorrhage • Miscellaneous problems when drainage is to be used as a therapeutic maneuver. Monitoring can also be used to evaluate the status pre- and postoperatively for space-occupying lesions.

Source page: https://510kreport.com/device/K243676
Methodology: https://510kreport.com/methodology