510(k) · Cleared
ClearedHakim Programmable Valve System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Johnson & Johnson Professionals, Inc. · JXG Shunt, Central Nervous System And Components
Cleared on Jul 1, 1998 as substantially equivalent to K944222 (Johnson & Johnson Professionals, Inc., 1995) after a 194-day review. Its family tree reaches back 1 generation to 1995. 1 of the 44 devices in its family, counting itself, has a Class I recall. 42 later devices descend from it.
- Decided
- Jul 1, 1998
- Review
- 194 days
- Class
- Class II
- Product code
- JXG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K944222 (1995). 42 later devices descend from it, 10 citing it directly. 1 of the 44 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK944222 Codman-Medos Valve Shunt SystemJohnson & Johnson Professionals, Inc. · 1995
- This deviceK974739 Hakim Programmable Valve SystemJohnson & Johnson Professionals, Inc. · 1998
- Descendant · cites it directly · 29 of its ownK992465 Sophy SU8 Pressure Adjustable ValveSophysa SA · 2000
- Descendant · cites it directly · 25 of its ownK012052 Medtronic PS Medical Strata Valve, Models 42855, 42865, 92865, 92855Medtronic PS Medical · 2002
- Descendant · 2 generations on · 23 of its ownK033850 Medtronic PS Medical Strata NSC Valve and Shunt Assemblies with and…Medtronic Neurosurgery · 2004 · Recalled
- Descendant · 2 generations on · 19 of its ownK042465 PS Medical Strata II ValveMedtronic Neurosurgery · 2004 · Recalled
- Descendant · 2 generations on · 9 of its ownK013488 Sophy Pressure Adjustable Valve System Model SM8Sophysa SA · 2002
Showing 5 of 42 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K152700 StrataMR Valves and Shunts3 generations on · 2016
Most influential descendants
Showing 5 of 42 · See all- K992465Sophy SU8 Pressure Adjustable ValveSophysa SA · 2000 · cites it directly29descendants
- K012052Medtronic PS Medical Strata Valve, Models 42855, 42865, 92865, 92855Medtronic PS Medical · 2002 · cites it directly25descendants
- K033850Medtronic PS Medical Strata NSC Valve and Shunt Assemblies with and Without BioglideMedtronic Neurosurgery · 2004 · 2 generations on23descendants
- K042465PS Medical Strata II ValveMedtronic Neurosurgery · 2004 · 2 generations on19descendants
- K013488Sophy Pressure Adjustable Valve System Model SM8Sophysa SA · 2002 · 2 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K944222 | Codman-Medos Valve Shunt System | Johnson & Johnson Professionals, Inc. | 1995 | — |
| 0 (this device) | K974739 | Hakim Programmable Valve System | Johnson & Johnson Professionals, Inc. | 1998 | — |
| +1 | K992465 | Sophy SU8 Pressure Adjustable Valve | Sophysa SA | 2000 | — |
| +1 | K012052 | Medtronic PS Medical Strata Valve, Models 42855, 42865, 92865, 92855 | Medtronic PS Medical | 2002 | — |
| +2 | K033850 | Medtronic PS Medical Strata NSC Valve and Shunt Assemblies with and Without… | Medtronic Neurosurgery | 2004 | 2 |
| +2 | K042465 | PS Medical Strata II Valve | Medtronic Neurosurgery | 2004 | 4 |
| +2 | K013488 | Sophy Pressure Adjustable Valve System Model SM8 | Sophysa SA | 2002 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2002 | 3 | 0 |
| 2004 | 5 | 0 |
| 2005 | 2 | 0 |
| 2006 | 3 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 3 | 0 |
| 2013 | 1 | 0 |
| 2015 | 3 | 0 |
| 2016 | 1 | 1 |
| 2017 | 2 | 0 |
| 2018 | 3 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new JXG device
- #1 K243531 Codman Libertís Shunt Catheter with Bactiseal…score 11.9 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K944222 | Codman-Medos Valve Shunt SystemSummary page 2…Comparison The HP Valve System is substantially equivalent in terms of intended use, materials, design, manufacturing, and function to the HAKIM Precision Valve System (K944222). Both devices utilize the same ball-in-cone valve mechanism to maintain intraventricular pressure. The valve design maintains in… | 1995 |
What descends from it? (42)
See all 4210 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K992465 | Sophy SU8 Pressure Adjustable Valve | 2000 | 29 |
| K012052 | Medtronic PS Medical Strata Valve, Models 42855, 42865, 92865, 92855 | 2002 | 25 |
| K020667 | Codman Hakim Shunt Systems | 2002 | 8 |
| K053350 | Modification to Codman Hakim Shunt Systems | 2006 | 5 |
| K122118 | Hakim Programmable and Precision Valve Shunt System | 2012 | 4 |
| K172022 | CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled) | 2017 | 3 |
| K112156 | Codman Certas Programmable Valve System, Codman Certas Therapy Management System | 2011 | 3 |
| K152152 | Codman Certas Plus Programmable Valve | 2015 | 2 |
| K091346 | Codman Hakim Micro II Valve | 2009 | 0 |
| K053107 | Codman Hakim Programmable Valve W/WO Siphonguard | 2006 | 0 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K152700StrataMR Valves and ShuntsMedtronic Neurosurgery · 2016 · 3 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
What does this lineage say?
How does its category compare?
All JXG devicesJXG Shunt, Central Nervous System And Components: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JXG
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JXG
255in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JXG
3in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JXG
1,198in 2025
MAUDE reports naming product code JXG, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 3 | 184 | 0 | 649 |
| 2008 | 6 | 60 | 1 | 630 |
| 2009 | 5 | 106 | 30 | 629 |
| 2010 | 3 | 30 | 0 | 812 |
| 2011 | 7 | 136 | 5 | 787 |
| 2012 | 3 | 78 | 1 | 977 |
| 2013 | 3 | 108 | 14 | 1,004 |
| 2014 | 0 | — | 6 | 1,251 |
| 2015 | 6 | 276 | 0 | 984 |
| 2016 | 6 | 143 | 0 | 1,091 |
| 2017 | 7 | 90 | 1 | 1,335 |
| 2018 | 6 | 102 | 0 | 1,484 |
| 2019 | 4 | 101 | 0 | 1,295 |
| 2020 | 2 | — | 8 | 1,206 |
| 2021 | 1 | — | 0 | 1,467 |
| 2022 | 4 | 101 | 0 | 1,329 |
| 2023 | 5 | 134 | 2 | 1,221 |
| 2024 | 3 | 90 | 3 | 1,214 |
| 2025 | 8 | 255 | 0 | 1,198 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
The HP Valve System is an implantable device that provides constant intraventricular pressure and drainage of cerebrospinal fluid (CSF) for the management of hydrocephalus.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K974739 · printed Nov 6, 2026
Cite this page
510(k) Report. “K974739: Hakim Programmable Valve System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K974739
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026