510(k) · Cleared
ClearedM. Blue Adjustable Shunt System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aesculap, Inc. · JXG Shunt, Central Nervous System And Components
Cleared on Nov 21, 2019 as substantially equivalent to K161853 (Aesculap, Inc., 2017) after a 92-day review. Its family tree reaches back 10 generations to 1995.
- Decided
- Nov 21, 2019
- Review
- 92 days
- Class
- Class II
- Product code
- JXG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K944222 (1995). 22 ancestors in all, the oldest K861377 (1986). No later device cites it as a predicate yet.
- Root · 10 generations backK944222 Codman-Medos Valve Shunt SystemJohnson & Johnson Professionals, Inc. · 1995
- 6 generations between
- 3 generations backK103003 Aesculap- Meithke Progav Programmable Shunt SystemAesculap, Inc. · 2010 · Recalled
- 2 generations backK120559 Aesculap-Meithke Prosa Adjustable Shunt SystemAesculap, Inc. · 2012 · Recalled
- 1 generation backK161853 proGAV Programmable Shunt System, proGAV 2.0 Adjustable Shunt…Aesculap, Inc. · 2017 · Recalled
- This deviceK192266 M. Blue Adjustable Shunt SystemAesculap, Inc. · 2019
Show all 10 generations
- Root · 10 generations backK944222 Codman-Medos Valve Shunt SystemJohnson & Johnson Professionals, Inc. · 1995
- 9 generations backK973774 Codman Hakim Micro Precision ValveJohnson & Johnson Professionals, Inc. · 1997
- 8 generations backK980778 Hakim Micro Programmable Valve SystemJohnson & Johnson Professionals, Inc. · 1998
- 7 generations backK012052 Medtronic PS Medical Strata Valve, Models 42855, 42865, 92865, 92855Medtronic PS Medical · 2002
- 6 generations backK033850 Medtronic PS Medical Strata NSC Valve and Shunt Assemblies with and…Medtronic Neurosurgery · 2004 · Recalled
- 5 generations backK042465 PS Medical Strata II ValveMedtronic Neurosurgery · 2004 · Recalled
- 4 generations backK062009 Aesculap-Meithke Progav Programmable Valve, Models FV410T-FV451TAesculap, Inc. · 2007
- 3 generations backK103003 Aesculap- Meithke Progav Programmable Shunt SystemAesculap, Inc. · 2010 · Recalled
- 2 generations backK120559 Aesculap-Meithke Prosa Adjustable Shunt SystemAesculap, Inc. · 2012 · Recalled
- 1 generation backK161853 proGAV Programmable Shunt System, proGAV 2.0 Adjustable Shunt…Aesculap, Inc. · 2017 · Recalled
- This deviceK192266 M. Blue Adjustable Shunt SystemAesculap, Inc. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K944222 | Codman-Medos Valve Shunt System | Johnson & Johnson Professionals, Inc. | 1995 | — |
| −9 | K973774 | Codman Hakim Micro Precision Valve | Johnson & Johnson Professionals, Inc. | 1997 | — |
| −8 | K980778 | Hakim Micro Programmable Valve System | Johnson & Johnson Professionals, Inc. | 1998 | — |
| −7 | K012052 | Medtronic PS Medical Strata Valve, Models 42855, 42865, 92865, 92855 | Medtronic PS Medical | 2002 | — |
| −6 | K033850 | Medtronic PS Medical Strata NSC Valve and Shunt Assemblies with and Without… | Medtronic Neurosurgery | 2004 | 2 |
| −5 | K042465 | PS Medical Strata II Valve | Medtronic Neurosurgery | 2004 | 4 |
| −4 | 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 | K120559 | Aesculap-Meithke Prosa Adjustable Shunt System | Aesculap, Inc. | 2012 | 2 |
| −1 | K161853 | proGAV Programmable Shunt System, proGAV 2.0 Adjustable Shunt System, proSA… | Aesculap, Inc. | 2017 | 1 |
| 0 (this device) | K192266 | M. Blue Adjustable Shunt System | Aesculap, Inc. | 2019 | — |
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 |
| 2002 | 2 | 0 |
| 2004 | 3 | 0 |
| 2011 | 1 | 0 |
| 2015 | 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 |
|---|---|---|---|
| * | K161853 | proGAV Programmable Shunt System, proGAV 2.0 Adjustable Shunt System, proSA Adjustable…Summary page 4…lap, Inc. believes that the Aesculap Miethke M.blue Adjustable Shunt System is substantially equivalent to the predicate, Aesculap Miethke proSA Adjustable Shunt System (K161853) and reference device, Miethke Shunt System miniNAV Valve (K110206). DEVICE DESCRIPTION M.blue is an adjustable valve that combi… | 2017 |
| † | K110206 | Aesculap- Meithke Shunt System | 2011 |
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?
- The line of descent spans 24 years and passes through 4 companies; a new generation was cleared every 2.4 years on median.
- 9 of the 22 ancestors have a recall of any class.
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. 2019, 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 M.blue Adjustable Shunt System is used for cerebrospinal fluid (CSF) shunting.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192266 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192266: M. Blue Adjustable Shunt System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192266
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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