510(k) · Cleared
ClearedMedtronic PS Medical Strata Valve
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Neurosurgery · JXG Shunt, Central Nervous System And Components
Cleared on Jun 15, 2004 after a 64-day review. The FDA summary names its predicate without a number. 1 of the 23 devices in its family, counting itself, has a Class I recall. 22 later devices descend from it.
- Decided
- Jun 15, 2004
- Review
- 64 days
- Class
- Class II
- Product code
- JXG
- Recalls
- None
- Predicates
- 0
22 later devices descend from it, 5 citing it directly. 1 of the 23 devices in this family, counting this one, has a Class I recall.
- This deviceK040943 Medtronic PS Medical Strata ValveMedtronic Neurosurgery · 2004
- Descendant · cites it directly · 19 of its ownK042465 PS Medical Strata II ValveMedtronic Neurosurgery · 2004 · Recalled
- Descendant · cites it directly · 7 of its ownK060681 Medtronic PS Medical Strata Type ValueMedtronic Neurosurgery · 2006 · Recalled
- Descendant · 2 generations on · 6 of its ownK062009 Aesculap-Meithke Progav Programmable Valve, Models FV410T-FV451TAesculap, Inc. · 2007
- Descendant · 3 generations on · 4 of its ownK103003 Aesculap- Meithke Progav Programmable Shunt SystemAesculap, Inc. · 2010 · Recalled
- Descendant · 2 generations on · 3 of its ownK110206 Aesculap- Meithke Shunt SystemAesculap, Inc. · 2011 · Recalled
Showing 5 of 22 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K152700 StrataMR Valves and Shunts2 generations on · 2016
Most influential descendants
Showing 5 of 22 · See all- K042465PS Medical Strata II ValveMedtronic Neurosurgery · 2004 · cites it directly19descendants
- K060681Medtronic PS Medical Strata Type ValueMedtronic Neurosurgery · 2006 · cites it directly7descendants
- K062009Aesculap-Meithke Progav Programmable Valve, Models FV410T-FV451TAesculap, Inc. · 2007 · 2 generations on6descendants
- K103003Aesculap- Meithke Progav Programmable Shunt SystemAesculap, Inc. · 2010 · 3 generations on4descendants
- K110206Aesculap- Meithke Shunt SystemAesculap, Inc. · 2011 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K040943 | Medtronic PS Medical Strata Valve | Medtronic Neurosurgery | 2004 | — |
| +1 | K042465 | PS Medical Strata II Valve | Medtronic Neurosurgery | 2004 | 4 |
| +1 | K060681 | Medtronic PS Medical Strata Type Value | Medtronic Neurosurgery | 2006 | 2 |
| +2 | K062009 | Aesculap-Meithke Progav Programmable Valve, Models FV410T-FV451T | Aesculap, Inc. | 2007 | — |
| +3 | K103003 | Aesculap- Meithke Progav Programmable Shunt System | Aesculap, Inc. | 2010 | 5 |
| +2 | K110206 | Aesculap- Meithke Shunt System | Aesculap, Inc. | 2011 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 1 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2021 | 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.
1 device in this family has a Class I recall. 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 |
|---|---|---|---|
| * | — | Medtronic PS Medical Strata Valve Named without a submission number |
What descends from it? (22)
See all 225 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K152700StrataMR Valves and ShuntsMedtronic Neurosurgery · 2016 · 2 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K042465 (Medtronic Neurosurgery, 2004) has gone furthest, with 19 descendants of its own.
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 Strata® Valve is a shunt component designed to provide continued Cerebrospinal Fluid (CSF) flow from the ventricles of the brain into the right atrium of the heart or the peritoneal cavity. The design allows the physician to non-invasively adjust valve pressure/flow performance level pre- and post-implantation by using an external magnetic Adjustment Tool without the need for radiographic confirmation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040943 · printed Nov 4, 2026
Cite this page
510(k) Report. “K040943: Medtronic PS Medical Strata Valve.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K040943
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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