# K053107: Codman Hakim Programmable Valve W/WO Siphonguard

- Pathway: 510(k) (Special)
- Applicant: Codman & Shurtleff, Inc.
- Decided: Jan 19, 2006 after 76 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 K944222 (1995). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041296: Modification to Hakim Precision Valve System, Hakim Programmable Valve System, Hakim Micro Programmable Valve System, SI, Codman & Shurtleff, Inc. (2004) Summary page 1.
- K020667: Codman Hakim Shunt Systems, Codman & Shurtleff, Inc. (2002) Summary page 1.
- K992173: Siphonguard CSF Control Device, Johnson & Johnson Professionals, Inc. (2000) Summary page 1.
- K980778: Hakim Micro Programmable Valve System, Johnson & Johnson Professionals, Inc. (1998) Summary page 1.
- K974739: Hakim Programmable Valve System, Johnson & Johnson Professionals, Inc. (1998) Summary page 1.

## Indications for use
The Codman HAKIM Programmable Valves (CHPV) are implantable devices that provide constant intraventricular pressure and drainage of CSF for the management of hydrocephalus. The SIPHONGUARD device can be used as a component of hydrocephalus shunt systems to shunt CSF from the ventricles of the brain into the peritoneal cavity or right atrium of the heart. The SIPHONGUARD device is designed to reduce the potential hazards of excessive lowering of intraventricular pressure (with respect to atmospheric pressure) when a patient is in an upright position.

Source page: https://510kreport.com/device/K053107
Methodology: https://510kreport.com/methodology