# K200630: Medtronic External Drainage and Monitoring System, Medtronic External Drainage and Monitoring System, Becker Replacement Drainage Bags

- Pathway: 510(k) (Special)
- Applicant: Medtronic, Inc.
- Decided: Apr 9, 2020 after 30 days
- Product code: GWM (Device, Monitoring, Intracranial Pressure)
- Device class: 2
- Regulation: 21 CFR 882.1620
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K802100 (1980). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K802100: Intracranial Pressuring Monitoring Syst., Pudenz-Schulte Medical Research Corp. (1980) Summary page 5.

## Indications for use
Draining CSF and monitoring 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. The monitoring of the intracranial pressure (ICP) is indicated in selected patients with: 1. Severe head injury 2. Subarachnoid hemorrhage graded III, IV or V preoperatively 3. Reye’s 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 postoperative for space-occupying lesions.

Source page: https://510kreport.com/device/K200630
Methodology: https://510kreport.com/methodology