510(k) · Cleared
ClearedHakim Micro 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 17, 1998 as substantially equivalent to K973774 (Johnson & Johnson Professionals, Inc., 1997) after a 137-day review. Its family tree reaches back 2 generations to 1995. 1 of the 41 devices in its family, counting itself, has a Class I recall. 38 later devices descend from it.
- Decided
- Jul 17, 1998
- Review
- 137 days
- Class
- Class II
- Product code
- JXG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K944222 (1995). 38 later devices descend from it, 7 citing it directly. 1 of the 41 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK944222 Codman-Medos Valve Shunt SystemJohnson & Johnson Professionals, Inc. · 1995
- 1 generation backK973774 Codman Hakim Micro Precision ValveJohnson & Johnson Professionals, Inc. · 1997
- This deviceK980778 Hakim Micro Programmable Valve SystemJohnson & Johnson Professionals, Inc. · 1998
- 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 · cites it directly · 8 of its ownK020667 Codman Hakim Shunt SystemsCodman & Shurtleff, Inc. · 2002
- Descendant · 2 generations on · 7 of its ownK060681 Medtronic PS Medical Strata Type ValueMedtronic Neurosurgery · 2006 · Recalled
Showing 5 of 38 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 38 · See all- 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
- K020667Codman Hakim Shunt SystemsCodman & Shurtleff, Inc. · 2002 · cites it directly8descendants
- K060681Medtronic PS Medical Strata Type ValueMedtronic Neurosurgery · 2006 · 2 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K944222 | Codman-Medos Valve Shunt System | Johnson & Johnson Professionals, Inc. | 1995 | — |
| −1 | K973774 | Codman Hakim Micro Precision Valve | Johnson & Johnson Professionals, Inc. | 1997 | — |
| 0 (this device) | K980778 | Hakim Micro Programmable Valve System | Johnson & Johnson Professionals, Inc. | 1998 | — |
| +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 |
| +1 | K020667 | Codman Hakim Shunt Systems | Codman & Shurtleff, Inc. | 2002 | — |
| +2 | K060681 | Medtronic PS Medical Strata Type Value | Medtronic Neurosurgery | 2006 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 3 | 0 |
| 2004 | 3 | 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 | 2 | 0 |
| 2016 | 1 | 1 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 2 | 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 |
|---|---|---|---|
| * | K973774 | Codman Hakim Micro Precision ValveSummary page 2…e HMP Valve System is substantially equivalent in terms of intended use, materials, design, manufacturing, and function to the CODMAN HAKIM Micro Precision Valve System (K973774). Both devices utilize the same ball-in-cone valve mechanism to maintain intraventricular pressure. Depending on the CSF flow rat… | 1997 |
What descends from it? (38)
See all 387 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K012052 | Medtronic PS Medical Strata Valve, Models 42855, 42865, 92865, 92855 | 2002 | 25 |
| K020667 | Codman Hakim Shunt Systems | 2002 | 8 |
| K062009 | Aesculap-Meithke Progav Programmable Valve, Models FV410T-FV451T | 2007 | 6 |
| K172022 | CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled) | 2017 | 3 |
| K020728 | Miethke Shunt System | 2002 | 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?
- The line of descent spans 3 years and passes through 1 company; a new generation was cleared every 2.4 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K012052 (Medtronic PS Medical, 2002) has gone furthest, with 25 descendants of its own.
- 4 other devices also cite its predicate K973774.
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 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.
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/K980778 · printed Nov 6, 2026
Cite this page
510(k) Report. “K980778: Hakim Micro 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/K980778
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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