510(k) Report

510(k) · Cleared

Recalled · Class II · 2012

Miethke Shunt System

K020728510(k) SpecialCleared Apr 5, 200230-day reviewClass II21 CFR 882.4100Recalls 1

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

Aesculap, Inc. · HCA Catheter, Ventricular

Cleared on Apr 5, 2002 as substantially equivalent to K980778 (Johnson & Johnson Professionals, Inc., 1998) and 4 other predicates after a 30-day review. Its family tree reaches back 3 generations to 1995. 2 later devices descend from it. It has been recalled once.

Decided
Apr 5, 2002
Review
30 days
Class
Class II
Product code
HCA
Recalls
1
Predicates
6

Its longest line of descent runs back 3 generations to K944222 (1995). 7 ancestors in all, the oldest K861377 (1986). 2 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1996: 1 other ancestor1994: 1 other ancestor1990: 1 other ancestor1986: 1 other ancestor2020: 1 descendant cleared2024: 1 descendant clearedK944222 · Codman-Medos Valve Shunt System · Johnson & Johnson Professionals, Inc. · 1995K973774 · Codman Hakim Micro Precision Valve · Johnson & Johnson Professionals, Inc. · 1997K980778 · Hakim Micro Programmable Valve System · Johnson & Johnson Professionals, Inc. · 19981990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors 1 generation forward: 2 descendants K980778 · Hakim Micro Programmable Valve System · Johnson & Johnson Professionals, Inc. · 1998K973774 · Codman Hakim Micro Precision Valve · Johnson & Johnson Professionals, Inc. · 1997K944222 · Codman-Medos Valve Shunt System · Johnson & Johnson Professionals, Inc. · 19950
  1. Root · 3 generations backK944222 Codman-Medos Valve Shunt SystemJohnson & Johnson Professionals, Inc. · 1995
  2. 2 generations backK973774 Codman Hakim Micro Precision ValveJohnson & Johnson Professionals, Inc. · 1997
  3. 1 generation backK980778 Hakim Micro Programmable Valve SystemJohnson & Johnson Professionals, Inc. · 1998
  4. This deviceK020728 Miethke Shunt SystemAesculap, Inc. · 2002
  5. Descendant · cites it directly · 0 of its ownK242003 XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter SetAesculap, Inc. · 2024
  6. Descendant · cites it directly · 0 of its ownK200950 Ventricular CatheterAesculap, Inc. · 2020

Most influential descendants

Showing 2 of 2 · See all
  • K242003XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter SetAesculap, Inc. · 2024 · cites it directly0descendants
  • K200950Ventricular CatheterAesculap, Inc. · 2020 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K944222Codman-Medos Valve Shunt SystemJohnson & Johnson Professionals, Inc.1995—
−2K973774Codman Hakim Micro Precision ValveJohnson & Johnson Professionals, Inc.1997—
−1K980778Hakim Micro Programmable Valve SystemJohnson & Johnson Professionals, Inc.1998—
0 (this device)K020728Miethke Shunt SystemAesculap, Inc.2002—
+1K242003XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter SetAesculap, Inc.2024—
+1K200950Ventricular CatheterAesculap, Inc.2020—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198610
199010
199410
199610

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202010
202410
FIG. 1 — Lineage of K020728, 1995–2024Source: 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), 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 HCA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against? (6)

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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

TypeNumberDeviceApplicantDecidedRecalls
*K980778Hakim Micro Programmable Valve System
Summary page 1
…plicable ASTM and ISO standards. SUBSTANTIAL EQUIVALENCE The Aesculap Miethke Shunt System is essentially identical to the J & J Hakim Micro Programmable Valve System (K980778), Heyer-Schulte Novus (K961859), P/S Medtronic Bulton (K811410), P/S Medtronic Delta (K902783), Cordis NMT Gravity Compensating A…
Johnson & Johnson Professionals, Inc.1998—
*K961859Novus Standard and Pediatric Valves
Summary page 1
…. SUBSTANTIAL EQUIVALENCE The Aesculap Miethke Shunt System is essentially identical to the J & J Hakim Micro Programmable Valve System (K980778), Heyer-Schulte Novus (K961859), P/S Medtronic Bulton (K811410), P/S Medtronic Delta (K902783), Cordis NMT Gravity Compensating Accessory (K932429) and the Cord…
Integra Neurocare, LLC1996—
Kept off the family treeK811410FDA’s K811410 is Medi-Trace
Our OCR of the scanned summary read K811410, FDA’s number for Medi-Trace (Graphic Controls Corp.), which shares no word with the summary’s name for the device, “P/S Medtronic Bulton”, apart from generic ones like “system”. Kept off the family tree.
Summary page 1
…Aesculap Miethke Shunt System is essentially identical to the J & J Hakim Micro Programmable Valve System (K980778), Heyer-Schulte Novus (K961859), P/S Medtronic Bulton (K811410), P/S Medtronic Delta (K902783), Cordis NMT Gravity Compensating Accessory (K932429) and the Cordis NMT Hakim Standard/Pediatric…
Graphic Controls Corp.1981—
*K902783PS Medical Delta CSF-Flow Control Valve
Summary page 1
…s essentially identical to the J & J Hakim Micro Programmable Valve System (K980778), Heyer-Schulte Novus (K961859), P/S Medtronic Bulton (K811410), P/S Medtronic Delta (K902783), Cordis NMT Gravity Compensating Accessory (K932429) and the Cordis NMT Hakim Standard/Pediatric Valves (K861377). === Page 2 =…
Pudenz-Schulte Medical Research Corp.19905
*K932429Cordis Gravity Compensating Accessory
Summary page 1
…rammable Valve System (K980778), Heyer-Schulte Novus (K961859), P/S Medtronic Bulton (K811410), P/S Medtronic Delta (K902783), Cordis NMT Gravity Compensating Accessory (K932429) and the Cordis NMT Hakim Standard/Pediatric Valves (K861377). SERVICES, » %, C DEPARTMENT OF HEALTH & HUMAN SER…
Cordis Corp.19941
*K861377Standard/Pediatric Cordis Hydrocephalus Valves
Summary page 1
…), P/S Medtronic Bulton (K811410), P/S Medtronic Delta (K902783), Cordis NMT Gravity Compensating Accessory (K932429) and the Cordis NMT Hakim Standard/Pediatric Valves (K861377). SERVICES, » %, C DEPARTMENT OF HEALTH & HUMAN SERVICES . - Public Health Service REALY) oo Ha, & i, pel R…
Cordis Corp.1986—

Also cleared against K980778: 6 other devices →

What descends from it? (2)

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

NumberDeviceApplicantDecidedDescendants
K242003XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter SetAesculap, Inc.20240
K200950Ventricular CatheterAesculap, Inc.20200

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

Recalls of this device

DateClassRecallRoot causeReason
Jun 4, 2012Class IIZ-0805-2013Process controlThe 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 7 years and passes through 2 companies; a new generation was cleared every 2.4 years on median.
  • 2 of the 7 ancestors have a recall of any class.
  • Of its descendants, K242003 (Aesculap, Inc., 2024) has gone furthest, with 0 descendants of its own.
  • 6 other devices also cite its predicate K980778.

How does its category compare?

All HCA devices

HCA Catheter, Ventricular: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HCA

1in 2017

2013: 12017: 1
2007high 1 (2013) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HCA

Too few HCA 510(k)s in any year since 2007 to give a median.

Recalls per year · HCA

No recall names HCA since 2007.

Adverse event reports per year · HCA

1in 2021

2007: 82008: 32009: 12010: 42011: 192012: 12015: 22016: 12017: 32019: 22020: 12021: 1
2007high 19 (2011) · low 0 (2013)2025

MAUDE reports naming product code HCA, 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
20070—08
20080—03
20090—01
20100—04
20110—019
20120—01
20131—00
20140—00
20150—02
20160—01
20171—03
20180—00
20190—02
20200—01
20210—01
20220—00
20230—00
20240—00
20250—00
20260—0—

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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K980778

6 other devices cite the same predicate.

  • K172022CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled)Codman & Shurtleff, Inc. · 20171 recall
  • K091346Codman Hakim Micro II ValveCodman & Shurtleff, Inc. · 2009
  • K062009Aesculap-Meithke Progav Programmable Valve, Models FV410T-FV451TAesculap, Inc. · 2007
  • K053107Codman Hakim Programmable Valve W/WO SiphonguardCodman & Shurtleff, Inc. · 2006
  • K020667Codman Hakim Shunt SystemsCodman & Shurtleff, Inc. · 2002
  • K012052Medtronic PS Medical Strata Valve, Models 42855, 42865, 92865, 92855Medtronic PS Medical · 2002

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 HCA

The HCA category page

  • K161731Cleveland Multiport Ventricular Catheter SetParker Hannifin Corp. · 2017
  • K123605Smartflow CatheterMri Interventions, Inc. · 2013
  • K031123Codman Bactiseal Barium Striped CathetersCodman & Shurtleff, Inc. · 20031 recall
  • K021481Bresagen Catheter, Model CS-3000Bresagen, Inc. · 2002
  • K013005Act 11 MP Ventricular CatheterInnerspace, Inc. · 2002

https://510kreport.com/device/K020728 · printed Nov 4, 2026

Cite this page

510(k) Report. “K020728: Miethke Shunt System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K020728

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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