# K251598: Intellidrop

- Pathway: 510(k) (Traditional)
- Applicant: Brainspace, Inc.
- Decided: Dec 10, 2025 after 197 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
The Intellidrop system is indicated for use to provide external drainage of cerebrospinal fluid (CSF) and/or monitoring of CSF drainage and intracranial pressure (ICP) for ventricular or lumbar use.

Source page: https://510kreport.com/device/K251598
Methodology: https://510kreport.com/methodology