# K091346: Codman Hakim Micro II Valve

- Pathway: 510(k) (Special)
- Applicant: Codman & Shurtleff, Inc.
- Decided: Jun 2, 2009 after 26 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). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020667: Codman Hakim Shunt Systems, Codman & Shurtleff, Inc. (2002) 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.
- K973774: Codman Hakim Micro Precision Valve, Johnson & Johnson Professionals, Inc. (1997) Summary page 1.
- K944222: Codman-Medos Valve Shunt System, Johnson & Johnson Professionals, Inc. (1995) Summary page 1.

## 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 or 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/K091346
Methodology: https://510kreport.com/methodology