510(k) Report

510(k) · Cleared

Recalled · Class II · 2014

Aesculap -Miethke Shunt System

K011030510(k) TraditionalCleared Mar 1, 2002330-day reviewClass II21 CFR 882.5550Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Aesculap, Inc. · JXG Shunt, Central Nervous System And Components

Cleared on Mar 1, 2002 after a 330-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 10 later devices descend from it. It has been recalled once.

Decided
Mar 1, 2002
Review
330 days
Class
Class II
Product code
JXG
Recalls
1
Predicates
0

10 later devices descend from it, 6 citing it directly.

Descendants, by year cleared 2019: 2 descendants cleared2007: 1 descendant cleared2010: 2 descendants cleared2024: 1 descendant cleared2011: 1 descendant cleared2012: 1 descendant cleared2015: 1 descendant cleared2017: 1 descendant cleared200020052010201520202025
  1. This deviceK011030 Aesculap -Miethke Shunt SystemAesculap, Inc. · 2002
  2. Descendant · cites it directly · 6 of its ownK062009 Aesculap-Meithke Progav Programmable Valve, Models FV410T-FV451TAesculap, Inc. · 2007
  3. Descendant · 2 generations on · 4 of its ownK103003 Aesculap- Meithke Progav Programmable Shunt SystemAesculap, Inc. · 2010 · Recalled
  4. Descendant · cites it directly · 3 of its ownK110206 Aesculap- Meithke Shunt SystemAesculap, Inc. · 2011 · Recalled
  5. Descendant · 2 generations on · 2 of its ownK141687 Aesculap - Meithke Progav 2.0 Adjustable Shunt SystemAesculap, Inc. · 2015
  6. Descendant · cites it directly · 2 of its ownK120559 Aesculap-Meithke Prosa Adjustable Shunt SystemAesculap, Inc. · 2012 · Recalled

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2007: 12010: 22011: 12012: 12015: 12017: 12019: 22024: 1
2007high 2 (2010) · low 0 (2008)2026

Most influential descendants

Showing 5 of 10 · See all
  • 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
  • K141687Aesculap - Meithke Progav 2.0 Adjustable Shunt SystemAesculap, Inc. · 2015 · 2 generations on2descendants
  • K120559Aesculap-Meithke Prosa Adjustable Shunt SystemAesculap, Inc. · 2012 · cites it directly2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K011030Aesculap -Miethke Shunt SystemAesculap, Inc.2002—
+1K062009Aesculap-Meithke Progav Programmable Valve, Models FV410T-FV451TAesculap, Inc.2007—
+2K103003Aesculap- Meithke Progav Programmable Shunt SystemAesculap, Inc.20105
+1K110206Aesculap- Meithke Shunt SystemAesculap, Inc.20112
+2K141687Aesculap - Meithke Progav 2.0 Adjustable Shunt SystemAesculap, Inc.2015—
+1K120559Aesculap-Meithke Prosa Adjustable Shunt SystemAesculap, Inc.20122

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
201020
201110
201210
201510
201710
201920
202410
FIG. 1 — Lineage of K011030, 2002–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), 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. #1 K243531 Codman Libertís Shunt Catheter with Bactiseal…score 11.9 · 8 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (10)

6 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K062009Aesculap-Meithke Progav Programmable Valve, Models FV410T-FV451TAesculap, Inc.20076
K110206Aesculap- Meithke Shunt SystemAesculap, Inc.20113
K120559Aesculap-Meithke Prosa Adjustable Shunt SystemAesculap, Inc.20122
K242003XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter SetAesculap, Inc.20240
K190174Miethke Shunt System GAV 2.0 and SA 2.0 ValvesAesculap, Inc.20190
K091328Siphonx Gravitational Antisiphon DeviceSophysa SA20100

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Oct 24, 2014Class IIZ-0502-2015Labeling mix-upsAesculap Inc. (AIC (USA)) initiated a recall of Miethke Shunt System, Dual Switch Valve, due to incorrect product labeling on three units. The incorrect product labeling was the wrong expiration date, 2024-09, on the inner labeling of the…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K062009 (Aesculap, Inc., 2007) has gone furthest, with 6 descendants of its own.

How does its category compare?

All JXG devices

JXG 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

2007: 32008: 62009: 52010: 32011: 72012: 32013: 32015: 62016: 62017: 72018: 62019: 42020: 22021: 12022: 42023: 52024: 32025: 82026 (partial year): 2
2007high 8 (2025) · low 0 (2014)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JXG

255in 2025

2007: 184 days median2008: 60 days median2009: 106 days median2010: 30 days median2011: 136 days median2012: 78 days median2013: 108 days median2015: 276 days median2016: 143 days median2017: 90 days median2018: 102 days median2019: 101 days median2022: 101 days median2023: 134 days median2024: 90 days median2025: 255 days median
2007high 276 (2015) · low 30 (2010)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · JXG

3in 2024

2008: 12009: 302011: 52012: 12013: 142014: 62017: 12020: 82023: 22024: 32026 (partial year): 1
2007high 30 (2009) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JXG

1,198in 2025

2007: 6492008: 6302009: 6292010: 8122011: 7872012: 9772013: 1,0042014: 1,2512015: 9842016: 1,0912017: 1,3352018: 1,4842019: 1,2952020: 1,2062021: 1,4672022: 1,3292023: 1,2212024: 1,2142025: 1,198
2007high 1,484 (2018) · low 629 (2009)2025

MAUDE reports naming product code JXG, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200731840649
20086601630
2009510630629
20103300812
201171365787
20123781977
20133108141,004
20140—61,251
201562760984
2016614301,091
201779011,335
2018610201,484
2019410101,295
20202—81,206
20211—01,467
2022410101,329
2023513421,221
202439031,214
2025825501,198
20262—1—

More from Aesculap, Inc.

208 FDA decisions under this applicant name. See the company

  • K260044Ventricular Catheters, Thomale CatheterAesculap, Inc. · 2026
  • K242762Aesculap Aicon® Series Container SystemAesculap, Inc. · 2025
  • K242003XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter SetAesculap, Inc. · 2024
  • K223596SQ.line KERRISONAesculap, Inc. · 2023
  • K214041Aesculap AICON ContainerAesculap, Inc. · 2022

Recent decisions in JXG

The JXG category page

  • K260044Ventricular Catheters, Thomale CatheterAesculap, Inc. · 2026
  • K261004Codman® Distal Peritoneal Catheter, Barium Open End (82-1682); Codman® HOLTER® Peritoneal Catheter (SALMON…Integra Lifesciences Production Corporation · 2026
  • K251598IntellidropBrainspace, Inc. · 2025
  • K250636Sophy Mini Monopressure Valve (SM1)Sophysa · 2025
  • K252514Evac-MriPhasor Health, LLC · 2025

https://510kreport.com/device/K011030 · printed Nov 6, 2026

Cite this page

510(k) Report. “K011030: Aesculap -Miethke 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/K011030

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026