# K980778: Hakim Micro Programmable Valve System

- Pathway: 510(k) (Traditional)
- Applicant: Johnson & Johnson Professionals, Inc.
- Decided: Jul 17, 1998 after 137 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: 2 generations back to K944222 (1995). 2 ancestors in all.
38 later devices descend from it; 7 cite it directly.
1 of 41 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973774: Codman Hakim Micro Precision Valve, Johnson & Johnson Professionals, Inc. (1997) Summary page 2.

## Most influential descendants
- K012052: Medtronic PS Medical Strata Valve, Models 42855, 42865, 92865, 92855 (2002), 25 descendants of its own
- K033850: Medtronic PS Medical Strata NSC Valve and Shunt Assemblies with and Without Bioglide (2004), 23 descendants of its own
- K042465: PS Medical Strata II Valve (2004), 19 descendants of its own
- K020667: Codman Hakim Shunt Systems (2002), 8 descendants of its own
- K060681: Medtronic PS Medical Strata Type Value (2006), 7 descendants of its own

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

Source page: https://510kreport.com/device/K980778
Methodology: https://510kreport.com/methodology