510(k) · Cleared
Recalled · Class II · 2020CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled)
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 Oct 3, 2017 as substantially equivalent to K944222 (Johnson & Johnson Professionals, Inc., 1995) and 9 other predicates after a 90-day review. Its family tree reaches back 6 generations to 1995. 3 later devices descend from it. It has been recalled once.
- Decided
- Oct 3, 2017
- Review
- 90 days
- Class
- Class II
- Product code
- JXG
- Recalls
- 1
- Predicates
- 10
Its longest line of descent runs back 6 generations to K944222 (1995). 13 ancestors in all, the oldest K902783 (1990). 3 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK944222 Codman-Medos Valve Shunt SystemJohnson & Johnson Professionals, Inc. · 1995
- 5 generations backK973774 Codman Hakim Micro Precision ValveJohnson & Johnson Professionals, Inc. · 1997
- 4 generations backK980778 Hakim Micro Programmable Valve SystemJohnson & Johnson Professionals, Inc. · 1998
- 3 generations backK020667 Codman Hakim Shunt SystemsCodman & Shurtleff, Inc. · 2002
- 2 generations backK053350 Modification to Codman Hakim Shunt SystemsCodman & Shurtleff, Inc. · 2006
- 1 generation backK122118 Hakim Programmable and Precision Valve Shunt SystemCodman & Shurtleff, Inc. · 2012
- This deviceK172022 CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled)Codman & Shurtleff, Inc. · 2017
- Descendant · cites it directly · 1 of its ownK233445 Bactiseal Catheters; Bactiseal Barium Striped Catheters; Bactiseal…Integra Lifesciences Production Corporation · 2024
- Descendant · 2 generations on · 0 of its ownK243531 Codman Libertís Shunt Catheter with Bactiseal and Endexo TechnologyIntegra Lifesciences Production Corporation · 2025
- Descendant · cites it directly · 0 of its ownK221840 Hakim Programmable Valves, Hakim Precision Fixed Pressure ValvesIntegra Lifesciences Production Corporation · 2022
Most influential descendants
Showing 3 of 3 · See all- K233445Bactiseal Catheters; Bactiseal Barium Striped Catheters; Bactiseal Endoscopic…Integra Lifesciences Production Corporation · 2024 · cites it directly1descendant
- K243531Codman Libertís Shunt Catheter with Bactiseal and Endexo TechnologyIntegra Lifesciences Production Corporation · 2025 · 2 generations on0descendants
- K221840Hakim Programmable Valves, Hakim Precision Fixed Pressure ValvesIntegra Lifesciences Production Corporation · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K944222 | Codman-Medos Valve Shunt System | Johnson & Johnson Professionals, Inc. | 1995 | — |
| −5 | K973774 | Codman Hakim Micro Precision Valve | Johnson & Johnson Professionals, Inc. | 1997 | — |
| −4 | K980778 | Hakim Micro Programmable Valve System | Johnson & Johnson Professionals, Inc. | 1998 | — |
| −3 | K020667 | Codman Hakim Shunt Systems | Codman & Shurtleff, Inc. | 2002 | — |
| −2 | K053350 | Modification to Codman Hakim Shunt Systems | Codman & Shurtleff, Inc. | 2006 | — |
| −1 | K122118 | Hakim Programmable and Precision Valve Shunt System | Codman & Shurtleff, Inc. | 2012 | — |
| 0 (this device) | K172022 | CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled) | Codman & Shurtleff, Inc. | 2017 | — |
| +1 | K233445 | Bactiseal Catheters; Bactiseal Barium Striped Catheters; Bactiseal Endoscopic… | Integra Lifesciences Production Corporation | 2024 | — |
| +2 | K243531 | Codman Libertís Shunt Catheter with Bactiseal and Endexo Technology | Integra Lifesciences Production Corporation | 2025 | — |
| +1 | 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 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (11)
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 4…devices for this submission have been cleared by the FDA Device(s) under: Preamendment – HOLTER Catheters and UNI-SHUNT System K944222 – Codman HAKIM Shunt System & Ventricular Catheter K973774 – Codman HAKIM Micro Precision Valve… | 1995 |
| * | K973774 | Codman Hakim Micro Precision ValveSummary page 4…nder: Preamendment – HOLTER Catheters and UNI-SHUNT System K944222 – Codman HAKIM Shunt System & Ventricular Catheter K973774 – Codman HAKIM Micro Precision Valve K974739 – Codman HAKIM Programmable Valve System K980778 –… | 1997 |
| * | K974739 | Hakim Programmable Valve SystemSummary page 4…I-SHUNT System K944222 – Codman HAKIM Shunt System & Ventricular Catheter K973774 – Codman HAKIM Micro Precision Valve K974739 – Codman HAKIM Programmable Valve System K980778 – Codman HAKIM Micro Programmable Valve K99217… | 1998 |
| * | K980778 | Hakim Micro Programmable Valve SystemSummary page 4…m & Ventricular Catheter K973774 – Codman HAKIM Micro Precision Valve K974739 – Codman HAKIM Programmable Valve System K980778 – Codman HAKIM Micro Programmable Valve K992173 – Codman SiphonGuard CSF Control Device K020667… | 1998 |
| * | K992173 | Siphonguard CSF Control DeviceSummary page 4…Micro Precision Valve K974739 – Codman HAKIM Programmable Valve System K980778 – Codman HAKIM Micro Programmable Valve K992173 – Codman SiphonGuard CSF Control Device K020667 – Codman HAKIM Shunt System K041296 – Modificat… | 2000 |
| * | K020667 | Codman Hakim Shunt SystemsSummary page 4…grammable Valve System K980778 – Codman HAKIM Micro Programmable Valve K992173 – Codman SiphonGuard CSF Control Device K020667 – Codman HAKIM Shunt System K041296 – Modification to HAKIM Precision Valve System K053350 – Mo… | 2002 |
| * | K041296 | Modification to Hakim Precision Valve System, Hakim Programmable Valve System, Hakim…Summary page 4…man HAKIM Micro Programmable Valve K992173 – Codman SiphonGuard CSF Control Device K020667 – Codman HAKIM Shunt System K041296 – Modification to HAKIM Precision Valve System K053350 – Modification to Codman HAKIM Shunt System… | 2004 |
| * | K053350 | Modification to Codman Hakim Shunt SystemsSummary page 4…honGuard CSF Control Device K020667 – Codman HAKIM Shunt System K041296 – Modification to HAKIM Precision Valve System K053350 – Modification to Codman HAKIM Shunt System K102589 – Codman BACTISEAL Catheters K122118 – Modi… | 2006 |
| * | K102589 | Codman Bactiseal Catheters, Codman Bactiseal Evd CatheterSummary page 4…hunt System K041296 – Modification to HAKIM Precision Valve System K053350 – Modification to Codman HAKIM Shunt System K102589 – Codman BACTISEAL Catheters K122118 – Modification to Codman HAKIM Shunt System IV. Device C… | 2011 |
| * | K122118 | Hakim Programmable and Precision Valve Shunt SystemSummary page 4…HAKIM Precision Valve System K053350 – Modification to Codman HAKIM Shunt System K102589 – Codman BACTISEAL Catheters K122118 – Modification to Codman HAKIM Shunt System IV. Device Codman HAKIM Precision and Programmable Valves: Descrip… | 2012 |
| * | — | HOLTER Catheters and UNI-SHUNT System Named without a submission number |
What descends from it? (3)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 14, 2020 | Class II | Z-0724-2021 | Labeling Change Control | Mislabeled product-Bactiseal Ventricular Catheter with Bactiseal Shunt System(823073) mislabeled as Bactiseal Endoscopic Ventricular Catheter (823087) and vs. versa |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 2 companies; a new generation was cleared every 3.8 years on median.
- 1 of the 13 ancestors has a recall of any class.
- Of its descendants, K233445 (Integra Lifesciences Production Corporation, 2024) has gone furthest, with 1 descendant 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. 2017, 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 Codman 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 Codman HAKIM Programmable Valve System is an implantable device that provides constant intraventricular pressure and drainages of cerebral spinal fluid (CSF) for the management of hydrocephalus. The Codman HOLTER Lumboperitoneal (LP) Shunt is indicated for…
Read the full statement (221 words)
The Codman 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 Codman HAKIM Programmable Valve System is an implantable device that provides constant intraventricular pressure and drainages of cerebral spinal fluid (CSF) for the management of hydrocephalus.
The Codman HOLTER Lumboperitoneal (LP) Shunt is indicated for shunting cerebrospinal fluid when the lumbo-peritoneal route is the procedure of choice in the treatment of communicating hydrocephalus.
The Codman HOLTER Atrial Catheters are indicated for use to shunt cerebrospinal fluid, when shunting of cerebrospinal fluid to the atrium is the procedure of choice in the treatment of hydrocephalus.
The Codman HOLTER Ventricular Catheters are indicated for use to gain access to the ventricles for diagnostic purposes and in the treatment of hydrocephalus.
The Codman Medos Ventricular Catheter is indicated for use in the treatment of hydrocephalus as a component of a shunt system when draining or shunting of cerebrospinal fluid (CSF) is indicated.
The UNI-SHUNT System is indicated for use as a one-piece ventriculo-peritoneal shunt system for the palliative treatment of hydrocephalus. No other use is recommended.
The Codman BACTISEAL Catheters are indicated for use in the treatment of hydrocephalus as a component of a shunt system when draining or shunting of cerebrospinal fluid (CSF) is indicated.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K172022 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172022: CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172022
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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