510(k) · Cleared
Recalled · Class II · 2014Aesculap-Meithke Prosa 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 May 24, 2012 as substantially equivalent to K062009 (Aesculap, Inc., 2007) and 3 other predicates after a 90-day review. Its family tree reaches back 8 generations to 1995. 2 later devices descend from it. It has been recalled 2 times.
- Decided
- May 24, 2012
- Review
- 90 days
- Class
- Class II
- Product code
- JXG
- Recalls
- 2
- Predicates
- 4
Its longest line of descent runs back 8 generations to K944222 (1995). 19 ancestors in all, the oldest K861377 (1986). 2 later devices descend from it, 1 citing it directly.
- Root · 8 generations backK944222 Codman-Medos Valve Shunt SystemJohnson & Johnson Professionals, Inc. · 1995
- 7 generations backK973774 Codman Hakim Micro Precision ValveJohnson & Johnson Professionals, Inc. · 1997
- 6 generations backK980778 Hakim Micro Programmable Valve SystemJohnson & Johnson Professionals, Inc. · 1998
- 5 generations backK012052 Medtronic PS Medical Strata Valve, Models 42855, 42865, 92865, 92855Medtronic PS Medical · 2002
- 4 generations backK033850 Medtronic PS Medical Strata NSC Valve and Shunt Assemblies with and…Medtronic Neurosurgery · 2004 · Recalled
- 3 generations backK042465 PS Medical Strata II ValveMedtronic Neurosurgery · 2004 · Recalled
- 2 generations backK062009 Aesculap-Meithke Progav Programmable Valve, Models FV410T-FV451TAesculap, Inc. · 2007
- 1 generation backK103003 Aesculap- Meithke Progav Programmable Shunt SystemAesculap, Inc. · 2010 · Recalled
- This deviceK120559 Aesculap-Meithke Prosa Adjustable Shunt SystemAesculap, Inc. · 2012
- Descendant · cites it directly · 1 of its ownK161853 proGAV Programmable Shunt System, proGAV 2.0 Adjustable Shunt…Aesculap, Inc. · 2017 · Recalled
- Descendant · 2 generations on · 0 of its ownK192266 M. Blue Adjustable Shunt SystemAesculap, Inc. · 2019
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 |
|---|---|---|---|---|---|
| −8 | K944222 | Codman-Medos Valve Shunt System | Johnson & Johnson Professionals, Inc. | 1995 | — |
| −7 | K973774 | Codman Hakim Micro Precision Valve | Johnson & Johnson Professionals, Inc. | 1997 | — |
| −6 | K980778 | Hakim Micro Programmable Valve System | Johnson & Johnson Professionals, Inc. | 1998 | — |
| −5 | K012052 | Medtronic PS Medical Strata Valve, Models 42855, 42865, 92865, 92855 | Medtronic PS Medical | 2002 | — |
| −4 | K033850 | Medtronic PS Medical Strata NSC Valve and Shunt Assemblies with and Without… | Medtronic Neurosurgery | 2004 | 2 |
| −3 | K042465 | PS Medical Strata II Valve | Medtronic Neurosurgery | 2004 | 4 |
| −2 | K062009 | Aesculap-Meithke Progav Programmable Valve, Models FV410T-FV451T | Aesculap, Inc. | 2007 | — |
| −1 | K103003 | Aesculap- Meithke Progav Programmable Shunt System | Aesculap, Inc. | 2010 | 5 |
| 0 (this device) | K120559 | Aesculap-Meithke Prosa Adjustable Shunt System | Aesculap, Inc. | 2012 | — |
| +1 | K161853 | proGAV Programmable Shunt System, proGAV 2.0 Adjustable Shunt System, proSA… | Aesculap, Inc. | 2017 | 1 |
| +2 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2019 | 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? (4)
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 |
|---|---|---|---|
| * | K062009 | Aesculap-Meithke Progav Programmable Valve, Models FV410T-FV451TSummary page 1…XG SUBSTANTIAL EQUIVALENCE Aesculap, Inc. believes that the Aesculap Miethke proSA Adjustable Shunt System is substantially to Miethke proGAV Programmable Shunt System (K062009 / K1 03003) and Aesculap Miethke Shunt System (K01 1030/1 K1 10206). DEVICE DESCRIPTION proSA is an adjustable gravitational val… | 2007 |
| * | K103003 | Aesculap- Meithke Progav Programmable Shunt SystemSummary page 1…NTIAL EQUIVALENCE Aesculap, Inc. believes that the Aesculap Miethke proSA Adjustable Shunt System is substantially to Miethke proGAV Programmable Shunt System (K062009 / K1 03003) and Aesculap Miethke Shunt System (K01 1030/1 K1 10206). DEVICE DESCRIPTION proSA is an adjustable gravitational valve that can… | 2010 |
| * | K011030 | Aesculap -Miethke Shunt SystemSummary page 1…t the Aesculap Miethke proSA Adjustable Shunt System is substantially to Miethke proGAV Programmable Shunt System (K062009 / K1 03003) and Aesculap Miethke Shunt System (K01 1030/1 K1 10206). DEVICE DESCRIPTION proSA is an adjustable gravitational valve that can be set for a range of pressures. The proSA v… | 2002 |
| * | K110206 | Aesculap- Meithke Shunt SystemSummary page 1…lap Miethke proSA Adjustable Shunt System is substantially to Miethke proGAV Programmable Shunt System (K062009 / K1 03003) and Aesculap Miethke Shunt System (K01 1030/1 K1 10206). DEVICE DESCRIPTION proSA is an adjustable gravitational valve that can be set for a range of pressures. The proSA valve is com… | 2011 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K161853 | proGAV Programmable Shunt System, proGAV 2.0 Adjustable Shunt System, proSA Adjustable… | 2017 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 17, 2014 | Class II | Z-1012-2015 | Labeling False and Misleading | Some Miethke Shunt System accessories may have an incorrect MR safety symbol on the shelf box label. The label should have NO symbol but instead is marked with the MR conditional symbol. The product is MR unsafe. This information is only… |
| Dec 23, 2013 | Class II | Z-0989-2014 | Employee error | The accuracy is out of specification for the Aesculap proSA Adjustment Disc Size L. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 4 companies; a new generation was cleared every 2.2 years on median.
- 7 of the 19 ancestors have a recall of any class.
- Of its descendants, K161853 (Aesculap, Inc., 2017) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate K062009.
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. 2012, 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 Miethke proSA Adjustable Shunt System is intended to shunt cerebrospinal fluid (CSF) from the lateral ventricles of the brain into the peritoneum. Adjustments of the proSA shunt can be verified by using the verification instrument but must be confirmed by radiograph (x-ray).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120559 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120559: Aesculap-Meithke Prosa 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/K120559
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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