510(k) · Cleared
Recalled · Class II · 2021PS Medical Strata II 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 Oct 19, 2004 as substantially equivalent to K012052 (Medtronic PS Medical, 2002) and 2 other predicates after a 36-day review. Its family tree reaches back 5 generations to 1995. 1 of the 31 devices in its family, counting itself, has a Class I recall. 19 later devices descend from it. It has been recalled 4 times.
- Decided
- Oct 19, 2004
- Review
- 36 days
- Class
- Class II
- Product code
- JXG
- Recalls
- 4
- Predicates
- 3
Its longest line of descent runs back 5 generations to K944222 (1995). 11 ancestors in all, the oldest K861377 (1986). 19 later devices descend from it, 6 citing it directly. 1 of the 31 devices in this family, counting this one, has a Class I recall.
- Root · 5 generations backK944222 Codman-Medos Valve Shunt SystemJohnson & Johnson Professionals, Inc. · 1995
- 4 generations backK973774 Codman Hakim Micro Precision ValveJohnson & Johnson Professionals, Inc. · 1997
- 3 generations backK980778 Hakim Micro Programmable Valve SystemJohnson & Johnson Professionals, Inc. · 1998
- 2 generations backK012052 Medtronic PS Medical Strata Valve, Models 42855, 42865, 92865, 92855Medtronic PS Medical · 2002
- 1 generation backK033850 Medtronic PS Medical Strata NSC Valve and Shunt Assemblies with and…Medtronic Neurosurgery · 2004 · Recalled
- This deviceK042465 PS Medical Strata II ValveMedtronic Neurosurgery · 2004
- Descendant · cites it directly · 7 of its ownK060681 Medtronic PS Medical Strata Type ValueMedtronic Neurosurgery · 2006 · Recalled
- Descendant · cites it directly · 6 of its ownK062009 Aesculap-Meithke Progav Programmable Valve, Models FV410T-FV451TAesculap, Inc. · 2007
- Descendant · 2 generations on · 4 of its ownK103003 Aesculap- Meithke Progav Programmable Shunt SystemAesculap, Inc. · 2010 · Recalled
- Descendant · cites it directly · 3 of its ownK110206 Aesculap- Meithke Shunt SystemAesculap, Inc. · 2011 · Recalled
- Descendant · 2 generations on · 3 of its ownK112156 Codman Certas Programmable Valve System, Codman Certas Therapy…Medos International SARL · 2011 · Recalled
Showing 5 of 19 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 19 · See all- K060681Medtronic PS Medical Strata Type ValueMedtronic Neurosurgery · 2006 · cites it directly7descendants
- K062009Aesculap-Meithke Progav Programmable Valve, Models FV410T-FV451TAesculap, Inc. · 2007 · cites it directly6descendants
- K103003Aesculap- Meithke Progav Programmable Shunt SystemAesculap, Inc. · 2010 · 2 generations on4descendants
- K110206Aesculap- Meithke Shunt SystemAesculap, Inc. · 2011 · cites it directly3descendants
- K112156Codman Certas Programmable Valve System, Codman Certas Therapy Management SystemMedos International SARL · 2011 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K944222 | Codman-Medos Valve Shunt System | Johnson & Johnson Professionals, Inc. | 1995 | — |
| −4 | K973774 | Codman Hakim Micro Precision Valve | Johnson & Johnson Professionals, Inc. | 1997 | — |
| −3 | K980778 | Hakim Micro Programmable Valve System | Johnson & Johnson Professionals, Inc. | 1998 | — |
| −2 | K012052 | Medtronic PS Medical Strata Valve, Models 42855, 42865, 92865, 92855 | Medtronic PS Medical | 2002 | — |
| −1 | K033850 | Medtronic PS Medical Strata NSC Valve and Shunt Assemblies with and Without… | Medtronic Neurosurgery | 2004 | 2 |
| 0 (this device) | K042465 | PS Medical Strata II Valve | Medtronic Neurosurgery | 2004 | — |
| +1 | K060681 | Medtronic PS Medical Strata Type Value | Medtronic Neurosurgery | 2006 | 2 |
| +1 | K062009 | Aesculap-Meithke Progav Programmable Valve, Models FV410T-FV451T | Aesculap, Inc. | 2007 | — |
| +2 | K103003 | Aesculap- Meithke Progav Programmable Shunt System | Aesculap, Inc. | 2010 | 5 |
| +1 | K110206 | Aesculap- Meithke Shunt System | Aesculap, Inc. | 2011 | 2 |
| +2 | K112156 | Codman Certas Programmable Valve System, Codman Certas Therapy Management System | Medos International SARL | 2011 | 16 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1990 | 1 | 0 |
| 1995 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 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? (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 |
|---|---|---|---|
| * | K012052 | Medtronic PS Medical Strata Valve, Models 42855, 42865, 92865, 92855 | 2002 |
| * | K040943 | Medtronic PS Medical Strata ValveSummary page 1…Strata NSC Valve and Shunt Assemblies with and without BioGlide (KO120052, K040943, K033850) Description: The PS Medical Strata IIValve is an adjustable Valve designed for non- invasive pressure-flow adjustme… | 2004 |
| * | K033850 | Medtronic PS Medical Strata NSC Valve and Shunt Assemblies with and Without BioglideSummary page 1…SC Valve and Shunt Assemblies with and without BioGlide (KO120052, K040943, K033850) Description: The PS Medical Strata IIValve is an adjustable Valve designed for non- invasive pressure-flow adjustment. Int… | 2004 |
What descends from it? (19)
See all 196 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K060681 | Medtronic PS Medical Strata Type Value | 2006 | 7 |
| K062009 | Aesculap-Meithke Progav Programmable Valve, Models FV410T-FV451T | 2007 | 6 |
| K110206 | Aesculap- Meithke Shunt System | 2011 | 3 |
| K082127 | Strata NSC Burr Hole Valve, Model 42335; Shunt Assembly, Model 46635 | 2008 | 1 |
| K083076 | Strata Burr Hole Valve, Model 42836 and Strata Burr Hole Shunt Assembly, Model 46836 | 2008 | 0 |
| K052386 | Medtronic M2 Magnet Adjustment Tool | 2005 | 0 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 11, 2021 | Class II | Z-1115-2021 | Process control | Potential for variation in radiopaque marking visibility under radiographic imaging for adjustable and fixed-pressure valves that are used in the management of hydrocephalus |
| Jan 11, 2021 | Class II | Z-1116-2021 | Process control | Potential for variation in radiopaque marking visibility under radiographic imaging for adjustable and fixed-pressure valves that are used in the management of hydrocephalus |
| Jan 17, 2017 | Class II | Z-1121-2017 | Other | Medtronic Neurosurgery initiated a recall after receiving five (5) Product Experiences between February 15, 2015 and August 23, 2016 reporting of discrepancies between the pressure/performance level (PL) at which the valve was set and the… |
| Nov 18, 2013 | Class II | Z-0399-2014 | Other | Medtronic Neurosurgery is recalling the CSF-Unitized Shunts, Delta Shunt Assembly Kit, and the Strata II Shunt Assembly Kit because they were found to have label discrepancies. |
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?
- The line of descent spans 9 years and passes through 3 companies; a new generation was cleared every 1.9 years on median.
- 3 of the 11 ancestors have a recall of any class.
- Of its descendants, K060681 (Medtronic Neurosurgery, 2006) has gone furthest, with 7 descendants of its own.
- 5 other devices also cite its predicate K012052.
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 Medtronic PS Medical Strata II Valve and shunt assemblies with and without BioGlide are shunt components designed to provide continued 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/performance level pre- and post-implantation by using a special magnetic adjustment tool without the need for radiographic confirmation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042465 · printed Nov 5, 2026
Cite this page
510(k) Report. “K042465: PS Medical Strata II Valve.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K042465
Report an extraction error
Are you the manufacturer?
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