# K200456: Becker External Drainage and Monitoring System

- Pathway: 510(k) (Special)
- Applicant: Medtronic, Inc.
- Decided: Mar 26, 2020 after 30 days
- Product code: GWM (Device, Monitoring, Intracranial Pressure)
- Device class: 2
- Regulation: 21 CFR 882.1620
- Recalls of this device: 2 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K902257 (1990). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
2 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K984053: Becker External Drainage and Monitoring System, Medtronic PS Medical (1999) Summary page 6.

## Most influential descendants
- K243676: Duet External Drainage and Monitoring System (EDMS) (2025), 0 descendants of its own

## Recalls of this device
- Nov 1, 2024 · Class I · Z-0661-2025: Due to complaints received reporting cracks and/or leaks of the stopcocks associated with the external drainage and monitoring system (EDMS).
- Nov 1, 2024 · Class I · Z-0662-2025: Due to complaints received reporting cracks and/or leaks of the stopcocks associated with the external drainage and monitoring system (EDMS).

## Indications for use
Draining and monitoring of CSF flow from the lateral ventricles or lumbar subarachnoid space is indicated in selected patients to: 1. Reduce intracranial pressure (ICP), e.g., pre-, intra- or postoperative; 2. Monitor CSF chemistry, cytology, and physiology; 3. Provide temporary CSF drainage in patients with infected cerebrospinal fluid shunts. Monitoring of intracranial pressure (ICP) is indicated in selected patients with: 1. Severe head injury 2. Subarachnoid hemorrhage graded III, IV, or V preoperatively 3. Reyes syndrome or similar encephalopathies 4. Hydrocephalus 5. Intracranial hemorrhage 6. 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/K200456
Methodology: https://510kreport.com/methodology