# K221694: External Drainage System

- Pathway: 510(k) (Traditional)
- Applicant: Jmed (Shenzhen) Technology Limited
- Decided: Feb 9, 2023 after 244 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: 4 generations back to K920156 (1992). 4 ancestors in all.
No later device cites it as a predicate yet.
3 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191684: MoniTorr ICP External Drainage and Monitoring System, LimiTorr Volume Limiting External CSF Drainage System, Integra LifeSciences Corporation (2019) Summary page 4.

## Indications for use
External Drainage System allows for drainage of cerebrospinal fluid (CSF) from the lateral ventricles of the brain and the lumbar subarachnoid space in selected patients to reduce intracranial pressure (ICP).

Source page: https://510kreport.com/device/K221694
Methodology: https://510kreport.com/methodology