510(k) · Cleared
ClearedHakim Programmable and Precision Valve Shunt System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Codman & Shurtleff, Inc. · JXG Shunt, Central Nervous System And Components
Cleared on Aug 3, 2012 as substantially equivalent to K944222 (Johnson & Johnson Professionals, Inc., 1995) and 4 other predicates after a 17-day review. Its family tree reaches back 5 generations to 1995. 4 later devices descend from it.
- Decided
- Aug 3, 2012
- Review
- 17 days
- Class
- Class II
- Product code
- JXG
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 5 generations to K944222 (1995). 9 ancestors in all, the oldest K902783 (1990). 4 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK944222 Codman-Medos Valve Shunt SystemJohnson & Johnson Professionals, Inc. · 1995
- 4 generations backK973774 Codman Hakim Micro Precision ValveJohnson & Johnson Professionals, Inc. · 1997
- 3 generations backK980778 Hakim Micro Programmable Valve SystemJohnson & Johnson Professionals, Inc. · 1998
- 2 generations backK020667 Codman Hakim Shunt SystemsCodman & Shurtleff, Inc. · 2002
- 1 generation backK053350 Modification to Codman Hakim Shunt SystemsCodman & Shurtleff, Inc. · 2006
- This deviceK122118 Hakim Programmable and Precision Valve Shunt SystemCodman & Shurtleff, Inc. · 2012
- Descendant · cites it directly · 3 of its ownK172022 CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled)Codman & Shurtleff, Inc. · 2017 · Recalled
- Descendant · 2 generations on · 1 of its ownK233445 Bactiseal Catheters; Bactiseal Barium Striped Catheters; Bactiseal…Integra Lifesciences Production Corporation · 2024
- Descendant · 3 generations on · 0 of its ownK243531 Codman Libertís Shunt Catheter with Bactiseal and Endexo TechnologyIntegra Lifesciences Production Corporation · 2025
- Descendant · 2 generations on · 0 of its ownK221840 Hakim Programmable Valves, Hakim Precision Fixed Pressure ValvesIntegra Lifesciences Production Corporation · 2022
Most influential descendants
Showing 4 of 4 · See all- K172022CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled)Codman & Shurtleff, Inc. · 2017 · cites it directly3descendants
- K233445Bactiseal Catheters; Bactiseal Barium Striped Catheters; Bactiseal Endoscopic…Integra Lifesciences Production Corporation · 2024 · 2 generations on1descendant
- K243531Codman Libertís Shunt Catheter with Bactiseal and Endexo TechnologyIntegra Lifesciences Production Corporation · 2025 · 3 generations on0descendants
- K221840Hakim Programmable Valves, Hakim Precision Fixed Pressure ValvesIntegra Lifesciences Production Corporation · 2022 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K944222 | Codman-Medos Valve Shunt System | Johnson & Johnson Professionals, Inc. | 1995 | — |
| −4 | K973774 | Codman Hakim Micro Precision Valve | Johnson & Johnson Professionals, Inc. | 1997 | — |
| −3 | K980778 | Hakim Micro Programmable Valve System | Johnson & Johnson Professionals, Inc. | 1998 | — |
| −2 | K020667 | Codman Hakim Shunt Systems | Codman & Shurtleff, Inc. | 2002 | — |
| −1 | K053350 | Modification to Codman Hakim Shunt Systems | Codman & Shurtleff, Inc. | 2006 | — |
| 0 (this device) | K122118 | Hakim Programmable and Precision Valve Shunt System | Codman & Shurtleff, Inc. | 2012 | — |
| +1 | K172022 | CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled) | Codman & Shurtleff, Inc. | 2017 | 1 |
| +2 | K233445 | Bactiseal Catheters; Bactiseal Barium Striped Catheters; Bactiseal Endoscopic… | Integra Lifesciences Production Corporation | 2024 | — |
| +3 | K243531 | Codman Libertís Shunt Catheter with Bactiseal and Endexo Technology | Integra Lifesciences Production Corporation | 2025 | — |
| +2 | K221840 | Hakim Programmable Valves, Hakim Precision Fixed Pressure Valves | Integra Lifesciences Production Corporation | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2022 | 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.
Planning a device in JXG? 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? (5)
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 1…s 11 (21 CFR§ 882.5550) (JXG) Type of 5 10(k) Submission: Special 510(k) Basis for Submission: Materials Formulation Change Predicate Device(s): K944222 Codmano HakimS Shunt System K974739 Codman& HakimO Programmable Valve System… | 1995 |
| * | K974739 | Hakim Programmable Valve SystemSummary page 1…Basis for Submission: Materials Formulation Change Predicate Device(s): K944222 Codmano HakimS Shunt System K974739 Codman& HakimO Programmable Valve System K020667 Codman& Hakim®@ Shunt System… | 1998 |
| * | K020667 | Codman Hakim Shunt SystemsSummary page 1…K944222 Codmano HakimS Shunt System K974739 Codman& HakimO Programmable Valve System K020667 Codman& Hakim®@ Shunt System K053350 Modification to CodmanO Hakim® Shunt System… | 2002 |
| * | K053350 | Modification to Codman Hakim Shunt SystemsSummary page 1…K974739 Codman& HakimO Programmable Valve System K020667 Codman& Hakim®@ Shunt System K053350 Modification to CodmanO Hakim® Shunt System K992 173 Codman® SiphonGuard CSF Control D… | 2006 |
| * | K992173 | Siphonguard CSF Control DeviceSummary page 1…K020667 Codman& Hakim®@ Shunt System K053350 Modification to CodmanO Hakim® Shunt System K992 173 Codman® SiphonGuard CSF Control Device Device Description The Codman HAKIM® Pre… | 2000 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K172022 | CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled) | 2017 | 3 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 2 companies; a new generation was cleared every 3.7 years on median.
- 1 of the 9 ancestors has a recall of any class.
- Of its descendants, K172022 (Codman & Shurtleff, Inc., 2017) has gone furthest, with 3 descendants of its own.
- 7 other devices also cite its predicate K944222.
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. 2012, this device’s year, is highlighted.
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 Precision Valve System is an implantable device that provides constant intraventricular pressure and drainage of cerebral spinal fluid (CSF) for the management of hydrocephalus.
The HAKIM Programmable Valve System is an implantable device that provides constant intraventricular pressure and drainage of cerebral spinal fluid (CSF) for the management of hydrocephalus.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122118 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122118: Hakim Programmable and Precision Valve Shunt System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122118
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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