# K041296: Modification to Hakim Precision Valve System, Hakim Programmable Valve System, Hakim Micro Programmable Valve System, SI

- Pathway: 510(k) (Special)
- Applicant: Codman & Shurtleff, Inc.
- Decided: Jun 10, 2004 after 27 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
No predicates in its family tree.
5 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) HAKIM Precision Valve System: named in the summary without a submission number
- (no number) HAKIM Programmable Valve System: named in the summary without a submission number
- (no number) HAKIM Micro Programmable Valve System: named in the summary without a submission number
- (no number) SiphonGuard CSF Control Device: named in the summary without a submission number

## Most influential descendants
- K172022: CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled) (2017), 3 descendants of its own
- K233445: Bactiseal Catheters; Bactiseal Barium Striped Catheters; Bactiseal Endoscopic Ventricular Catheter (2024), 1 descendant of its own
- K243531: Codman Libertís Shunt Catheter with Bactiseal and Endexo Technology (2025), 0 descendants of its own
- K221840: Hakim Programmable Valves, Hakim Precision Fixed Pressure Valves (2022), 0 descendants of its own
- K053107: Codman Hakim Programmable Valve W/WO Siphonguard (2006), 0 descendants of its own

## Indications for use
The SiphonGuard device can be used as a component of hydrocephalus shunt systems designed to shunt CSF from the lateral 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. The HAKIM Precision Valve Shunt System is an implantable device that provides constant intraventricular pressure and drainage of CSF for the management of hydrocephalus. The HAKIM Micro Programmable Valve Shunt System is an implantable device that provides constant intraventricular pressure and drainage of CSF for the management of hydrocephalus. The HAKIM Programmable Valve Shunt System is an implantable device that provides constant intraventricular pressure and drainage of CSF for the management of hydrocephalus.

Source page: https://510kreport.com/device/K041296
Methodology: https://510kreport.com/methodology