# K122118: Hakim Programmable and Precision Valve Shunt System

- Pathway: 510(k) (Special)
- Applicant: Codman & Shurtleff, Inc.
- Decided: Aug 3, 2012 after 17 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 K944222 (1995). 9 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K944222: Codman-Medos Valve Shunt System, Johnson & Johnson Professionals, Inc. (1995) Summary page 1.
- K974739: Hakim Programmable Valve System, Johnson & Johnson Professionals, Inc. (1998) Summary page 1.
- K020667: Codman Hakim Shunt Systems, Codman & Shurtleff, Inc. (2002) Summary page 1.
- K053350: Modification to Codman Hakim Shunt Systems, Codman & Shurtleff, Inc. (2006) Summary page 1.
- K992173: Siphonguard CSF Control Device, Johnson & Johnson Professionals, Inc. (2000) Summary page 1.

## 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

## Indications for use
The HAKIM Precision Valve System is an implantable device that provides constant intraventricular pressure and drainage of cerebral spinal fluid (CSF) for the management of hydrocephalus. The HAKIM Programmable Valve System is an implantable device that provides constant intraventricular pressure and drainage of cerebral spinal fluid (CSF) for the management of hydrocephalus.

Source page: https://510kreport.com/device/K122118
Methodology: https://510kreport.com/methodology
