# K020667: Codman Hakim Shunt Systems

- Pathway: 510(k) (Special)
- Applicant: Codman & Shurtleff, Inc.
- Decided: Mar 28, 2002 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
Longest line of descent: 3 generations back to K944222 (1995). 7 ancestors in all.
8 later devices descend from it; 5 cite it directly.
0 of 16 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.
- K973774: Codman Hakim Micro Precision Valve, Johnson & Johnson Professionals, Inc. (1997) Summary page 1.
- K974739: Hakim Programmable Valve System, Johnson & Johnson Professionals, Inc. (1998) Summary page 1.
- K980778: Hakim Micro Programmable Valve System, Johnson & Johnson Professionals, Inc. (1998) Summary page 1.
- K992173: Siphonguard CSF Control Device, Johnson & Johnson Professionals, Inc. (2000) Summary page 1.
- K003322: Codman Bactiseal Catheters, Codman & Shurtleff, Inc. (2001) Summary page 1.

## Most influential descendants
- K053350: Modification to Codman Hakim Shunt Systems (2006), 5 descendants of its own
- K122118: Hakim Programmable and Precision Valve Shunt System (2012), 4 descendants of its own
- 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

## Indications for use
CODMAN HAKIM™ Shunt Systems are implantable devices that provide constant intraventricular pressure and drainage of cerebrospinal fluid for the management of hydrocephalus. CODMAN HAKIM™ Shunt Systems are available with or without CODMAN BACTISEAL™ Catheters, which are intended for use in the treatment of hydrocephalus as a component of a shunt system when draining or shunting of cerebrospinal fluid is indicated. CODMAN HAKIM™ Shunt Systems are also available with ar without SIPHONGUARD™, 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/K020667
Methodology: https://510kreport.com/methodology