510(k) · Cleared
ClearedCodman VPV System, Model 82-3192
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 16, 2006 as substantially equivalent to K050739 (Codman & Shurtleff, Inc., 2005) and 1 other predicate after a 105-day review. Its family tree reaches back 1 generation to 2004.
- Decided
- Oct 16, 2006
- Review
- 105 days
- Class
- Class II
- Product code
- JXG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K040943 (2004). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK040943 Medtronic PS Medical Strata ValveMedtronic Neurosurgery · 2004
- This deviceK061876 Codman VPV System, Model 82-3192Codman & Shurtleff, Inc. · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K040943 | Medtronic PS Medical Strata Valve | Medtronic Neurosurgery | 2004 | — |
| 0 (this device) | K061876 | Codman VPV System, Model 82-3192 | Codman & Shurtleff, Inc. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 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? (2)
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 |
|---|---|---|---|
| * | K050739 | Codman VPV System, Model 82-3192Summary page 1…06 C. Device Information Propriety / Trade Name: CODMAN® VPV TM System Common Name: Hydrocephalus Shunt System Predicate Device: CODMAN® VPVTM System (K050739) D. Classification This device has been placed in Class II for Central Nervous System Fluid Shunt and Components de… | 2005 |
| * | K040943 | Medtronic PS Medical Strata ValveSummary page 2…physical characteristics, programming and procedure. The CODMAN VPV System is substantially equivalent to Medtronic's PS Medical Strata®D Valves and Handtools (K040943) with regard to Indications for Use and labeling. CONFIDENTIAL 16… | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- None of the 2 ancestors has a recall.
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 CODMAN® VPVTM System is designed for use only with CODMAN® HAKIM TM Programmable Valves in the treatment of hydrocephalus when shunting cerebrospinal fluid (CSF) from the ventricles of the brain. It is used to non-invasively adjust the CODMAN HAKIM Programmable Valve to the selected setting and provides confirmation of the valve adjustment, without the need for radiographic imaging when an "Adjustment Complete" message is displayed.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061876 · printed Nov 4, 2026
Cite this page
510(k) Report. “K061876: Codman VPV System, Model 82-3192.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061876
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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