# K181301: Smart External Drain (SED) System

- Pathway: 510(k) (Special)
- Applicant: Aqueduct Critical Care, Inc.
- Decided: Jun 14, 2018 after 28 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: 5 generations back to K902257 (1990). 6 ancestors in all.
No later device cites it as a predicate yet.
1 of 7 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172759: Smart External Drain (SED) System, Aqueduct Critical Care, Inc. (2017) Summary page 6.

## Indications for use
Draining and monitoring of CSF flow from the lateral ventricles or lumbar subarachnoid space is indicated 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 • Reye's 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/K181301
Methodology: https://510kreport.com/methodology