510(k) · Cleared
ClearedCodman Certas Plus Programmable Valve
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medos International SARL · JXG Shunt, Central Nervous System And Components
Cleared on Oct 27, 2015 as substantially equivalent to K974739 (Johnson & Johnson Professionals, Inc., 1998) after an 85-day review. Its family tree reaches back 2 generations to 1995. 2 later devices descend from it.
- Decided
- Oct 27, 2015
- Review
- 85 days
- Class
- Class II
- Product code
- JXG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K944222 (1995). 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK944222 Codman-Medos Valve Shunt SystemJohnson & Johnson Professionals, Inc. · 1995
- 1 generation backK974739 Hakim Programmable Valve SystemJohnson & Johnson Professionals, Inc. · 1998
- This deviceK152152 Codman Certas Plus Programmable ValveMedos International SARL · 2015
- Descendant · cites it directly · 1 of its ownK182265 CodMan Certas Plus Programmable ValveIntegra Lifesciences Corp. · 2018
- Descendant · cites it directly · 0 of its ownK223330 Certas Plus Programmable ValvesIntegra Lifesciences Production Corporation · 2023 · Recalled
Most influential descendants
Showing 2 of 2 · See allView 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 | K974739 | Hakim Programmable Valve System | Johnson & Johnson Professionals, Inc. | 1998 | — |
| 0 (this device) | K152152 | Codman Certas Plus Programmable Valve | Medos International SARL | 2015 | — |
| +1 | K182265 | CodMan Certas Plus Programmable Valve | Integra Lifesciences Corp. | 2018 | — |
| +1 | K223330 | Certas Plus Programmable Valves | Integra Lifesciences Production Corporation | 2023 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2023 | 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? (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 |
|---|---|---|---|
| * | K974739 | Hakim Programmable Valve SystemSummary page 4…(21 CFR 882.5550) Regulatory Class II Product Code JXG III. Predicate Codman Hakim Programmable Valve, K974739. Device The following reference devices were used in this submission: Codman Certas Plus Progra… | 1998 |
| † | K143111 | Codman Certas Plus Programmable Valve; Codman Certas Toll Kit | 2015 |
| † | K112156 | Codman Certas Programmable Valve System, Codman Certas Therapy Management System | 2011 |
What descends from it? (2)
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 20 years and passes through 2 companies; a new generation was cleared every 17.3 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K182265 (Integra Lifesciences Corp., 2018) has gone furthest, with 1 descendant of its own.
- 9 other devices also cite its predicate K974739.
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. 2015, 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 Certas Plus Programmable Valve is an implantable device that provides constant intraventricular pressure and drainage of CSF for the management of hydrocephalus.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K152152 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152152: Codman Certas Plus Programmable Valve.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152152
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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