510(k) · Cleared
Recalled · Class II · 2014Aesculap- Meithke 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 Oct 27, 2011 as substantially equivalent to K011030 (Aesculap, Inc., 2002) and 1 other predicate after a 275-day review. Its family tree reaches back 6 generations to 1995. 3 later devices descend from it. It has been recalled 2 times.
- Decided
- Oct 27, 2011
- Review
- 275 days
- Class
- Class II
- Product code
- JXG
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 6 generations to K944222 (1995). 13 ancestors in all, the oldest K861377 (1986). 3 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK944222 Codman-Medos Valve Shunt SystemJohnson & Johnson Professionals, Inc. · 1995
- 5 generations backK973774 Codman Hakim Micro Precision ValveJohnson & Johnson Professionals, Inc. · 1997
- 4 generations backK980778 Hakim Micro Programmable Valve SystemJohnson & Johnson Professionals, Inc. · 1998
- 3 generations backK012052 Medtronic PS Medical Strata Valve, Models 42855, 42865, 92865, 92855Medtronic PS Medical · 2002
- 2 generations backK033850 Medtronic PS Medical Strata NSC Valve and Shunt Assemblies with and…Medtronic Neurosurgery · 2004 · Recalled
- 1 generation backK042465 PS Medical Strata II ValveMedtronic Neurosurgery · 2004 · Recalled
- This deviceK110206 Aesculap- Meithke Shunt SystemAesculap, Inc. · 2011
- Descendant · cites it directly · 2 of its ownK120559 Aesculap-Meithke Prosa Adjustable Shunt SystemAesculap, Inc. · 2012 · Recalled
- Descendant · 2 generations on · 1 of its ownK161853 proGAV Programmable Shunt System, proGAV 2.0 Adjustable Shunt…Aesculap, Inc. · 2017 · Recalled
- Descendant · 3 generations on · 0 of its ownK192266 M. Blue Adjustable Shunt SystemAesculap, Inc. · 2019
Most influential descendants
Showing 3 of 3 · See all- K120559Aesculap-Meithke Prosa Adjustable Shunt SystemAesculap, Inc. · 2012 · cites it directly2descendants
- K161853proGAV Programmable Shunt System, proGAV 2.0 Adjustable Shunt System, proSA Adjustable…Aesculap, Inc. · 2017 · 2 generations on1descendant
- K192266M. Blue Adjustable Shunt SystemAesculap, Inc. · 2019 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K944222 | Codman-Medos Valve Shunt System | Johnson & Johnson Professionals, Inc. | 1995 | — |
| −5 | K973774 | Codman Hakim Micro Precision Valve | Johnson & Johnson Professionals, Inc. | 1997 | — |
| −4 | K980778 | Hakim Micro Programmable Valve System | Johnson & Johnson Professionals, Inc. | 1998 | — |
| −3 | K012052 | Medtronic PS Medical Strata Valve, Models 42855, 42865, 92865, 92855 | Medtronic PS Medical | 2002 | — |
| −2 | K033850 | Medtronic PS Medical Strata NSC Valve and Shunt Assemblies with and Without… | Medtronic Neurosurgery | 2004 | 2 |
| −1 | K042465 | PS Medical Strata II Valve | Medtronic Neurosurgery | 2004 | 4 |
| 0 (this device) | K110206 | Aesculap- Meithke Shunt System | Aesculap, Inc. | 2011 | — |
| +1 | K120559 | Aesculap-Meithke Prosa Adjustable Shunt System | Aesculap, Inc. | 2012 | 2 |
| +2 | K161853 | proGAV Programmable Shunt System, proGAV 2.0 Adjustable Shunt System, proSA… | Aesculap, Inc. | 2017 | 1 |
| +3 | 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 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 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? (2)
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 |
|---|---|---|---|
| * | K011030 | Aesculap -Miethke Shunt SystemSummary page 2…alve and McLanahan Valve and Miethke Shunt System are substantially equivalent to the Paedi-GAV PS Medical MonoStep Valve of the Miethke Shunt System (K01 1030) and Medtronic (K042465). The new Strata 11Valve and Shunt Asse… | 2002 |
| * | K042465 | PS Medical Strata II ValveSummary page 2…the Paedi-GAV PS Medical MonoStep Valve of the Miethke Shunt System (K01 1030) and Medtronic (K042465). The new Strata 11Valve and Shunt Assembies with and without BioGlide Valve. The miniNAV Valve is similar to the c… | 2004 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K120559 | Aesculap-Meithke Prosa Adjustable Shunt System | 2012 | 2 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 11, 2014 | Class III | Z-0814-2015 | Labeling Change Control | Aesculap Inc. (AIC (USA)) initiated a recall of Miethke Shunt System accessories due to missing patients' labels for the miniNAV (FV660T). There are no patient injuries resulting from this issue. |
| Jun 4, 2012 | Class II | Z-0805-2013 | Process control | The deflector may not move freely on the ventricular catheter. The deflector comes pre-positioned at the 5 cm mark on the catheter. In some cases the surgeon will want to adjust the deflector to a different location on the catheter before… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 4 companies; a new generation was cleared every 2.4 years on median.
- 5 of the 13 ancestors have a recall of any class.
- Of its descendants, K120559 (Aesculap, Inc., 2012) has gone furthest, with 2 descendants of its own.
- 5 other devices also cite its predicate K011030.
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. 2011, 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 Shunt System is intended to shunt cerebrospinal fluid (CSF) from the lateral ventricles of the brain into the peritoneum.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110206 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110206: Aesculap- Meithke 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/K110206
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