510(k) · Cleared
ClearedModification to Codman Hakim Shunt Systems
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 Jan 19, 2006 as substantially equivalent to K020667 (Codman & Shurtleff, Inc., 2002) and 2 other predicates after a 48-day review. Its family tree reaches back 4 generations to 1995. 5 later devices descend from it.
- Decided
- Jan 19, 2006
- Review
- 48 days
- Class
- Class II
- Product code
- JXG
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K944222 (1995). 8 ancestors in all, the oldest K902783 (1990). 5 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK944222 Codman-Medos Valve Shunt SystemJohnson & Johnson Professionals, Inc. · 1995
- 3 generations backK973774 Codman Hakim Micro Precision ValveJohnson & Johnson Professionals, Inc. · 1997
- 2 generations backK980778 Hakim Micro Programmable Valve SystemJohnson & Johnson Professionals, Inc. · 1998
- 1 generation backK020667 Codman Hakim Shunt SystemsCodman & Shurtleff, Inc. · 2002
- This deviceK053350 Modification to Codman Hakim Shunt SystemsCodman & Shurtleff, Inc. · 2006
- Descendant · cites it directly · 4 of its ownK122118 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 5 of 5 · See all- K122118Hakim Programmable and Precision Valve Shunt SystemCodman & Shurtleff, Inc. · 2012 · cites it directly4descendants
- 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 |
|---|---|---|---|---|---|
| −4 | K944222 | Codman-Medos Valve Shunt System | Johnson & Johnson Professionals, Inc. | 1995 | — |
| −3 | K973774 | Codman Hakim Micro Precision Valve | Johnson & Johnson Professionals, Inc. | 1997 | — |
| −2 | K980778 | Hakim Micro Programmable Valve System | Johnson & Johnson Professionals, Inc. | 1998 | — |
| −1 | K020667 | Codman Hakim Shunt Systems | Codman & Shurtleff, Inc. | 2002 | — |
| 0 (this device) | K053350 | Modification to Codman Hakim Shunt Systems | Codman & Shurtleff, Inc. | 2006 | — |
| +1 | 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 |
|---|---|---|
| 2012 | 1 | 0 |
| 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? (3)
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 |
|---|---|---|---|
| * | K020667 | Codman Hakim Shunt SystemsSummary page 1…t Classification Name: Central Nervous System Fluid Shunt and Components Regulation Number: 882.550 C. Predicate Device: Codman Hakim Shunt Systems (K020667). Codman Hakim Programmable Valve (K974739) Codman Hakim Precision Valve (K… | 2002 |
| * | K974739 | Hakim Programmable Valve SystemSummary page 1…mponents Regulation Number: 882.550 C. Predicate Device: Codman Hakim Shunt Systems (K020667). Codman Hakim Programmable Valve (K974739) Codman Hakim Precision Valve (K944222) D. Device Description: The Codman H-akim Shunt System inc… | 1998 |
| * | K944222 | Codman-Medos Valve Shunt SystemSummary page 1…Codman Hakim Shunt Systems (K020667). Codman Hakim Programmable Valve (K974739) Codman Hakim Precision Valve (K944222) D. Device Description: The Codman H-akim Shunt System incorporates all the possible shunt system… | 1995 |
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 11 years and passes through 2 companies; a new generation was cleared every 3.7 years on median.
- 1 of the 8 ancestors has a recall of any class.
- Of its descendants, K122118 (Codman & Shurtleff, Inc., 2012) has gone furthest, with 4 descendants of its own.
- 4 other devices also cite its predicate K020667.
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?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053350 · printed Nov 5, 2026
Cite this page
510(k) Report. “K053350: Modification to Codman Hakim Shunt Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K053350
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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