# K221840: Hakim Programmable Valves, Hakim Precision Fixed Pressure Valves

- Pathway: 510(k) (Traditional)
- Applicant: Integra Lifesciences Production Corporation
- Decided: Oct 14, 2022 after 112 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: 7 generations back to K944222 (1995). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172022: CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled), Codman & Shurtleff, Inc. (2017) Summary page 4.

## Indications for use
The Codman Hakim Precision Fixed Pressure Valve Systems are implantable devices that provide constant intraventricular pressure and drainage of cerebral spinal fluid (CSF) for the management of hydrocephalus. The Codman Hakim Programmable Valves Systems are implantable devices that provide constant intraventricular pressure and drainage of cerebral spinal fluid (CSF) for the management of hydrocephalus.

Source page: https://510kreport.com/device/K221840
Methodology: https://510kreport.com/methodology