510(k) Report

510(k) · Cleared

Cleared

Codman Hakim Micro II Valve

K091346510(k) SpecialCleared Jun 2, 200926-day reviewClass II21 CFR 882.5550

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

Codman & Shurtleff, Inc. · JXG Shunt, Central Nervous System And Components

Cleared on Jun 2, 2009 as substantially equivalent to K020667 (Codman & Shurtleff, Inc., 2002) and 4 other predicates after a 26-day review. Its family tree reaches back 4 generations to 1995.

Decided
Jun 2, 2009
Review
26 days
Class
Class II
Product code
JXG
Recalls
None
Predicates
5

Its longest line of descent runs back 4 generations to K944222 (1995). 8 ancestors in all, the oldest K902783 (1990). No later device cites it as a predicate yet.

Other ancestors, by year cleared 1998: 1 other ancestor2001: 1 other ancestor2000: 1 other ancestor1990: 1 other ancestorK944222 · 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. · 1998K020667 · Codman Hakim Shunt Systems · Codman & Shurtleff, Inc. · 200219901995200020052010
Other ancestors, by generation 1 generation back: 1 other ancestor2 generations back: 2 other ancestors3 generations back: 1 other ancestor K020667 · Codman Hakim Shunt Systems · Codman & Shurtleff, Inc. · 2002K980778 · 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 · 4 generations backK944222 Codman-Medos Valve Shunt SystemJohnson & Johnson Professionals, Inc. · 1995
  2. 3 generations backK973774 Codman Hakim Micro Precision ValveJohnson & Johnson Professionals, Inc. · 1997
  3. 2 generations backK980778 Hakim Micro Programmable Valve SystemJohnson & Johnson Professionals, Inc. · 1998
  4. 1 generation backK020667 Codman Hakim Shunt SystemsCodman & Shurtleff, Inc. · 2002
  5. This deviceK091346 Codman Hakim Micro II ValveCodman & Shurtleff, Inc. · 2009
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K944222Codman-Medos Valve Shunt SystemJohnson & Johnson Professionals, Inc.1995—
−3K973774Codman Hakim Micro Precision ValveJohnson & Johnson Professionals, Inc.1997—
−2K980778Hakim Micro Programmable Valve SystemJohnson & Johnson Professionals, Inc.1998—
−1K020667Codman Hakim Shunt SystemsCodman & Shurtleff, Inc.2002—
0 (this device)K091346Codman Hakim Micro II ValveCodman & Shurtleff, Inc.2009—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199010
199810
200010
200110
FIG. 1 — Lineage of K091346, 1995–2009Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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 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
Get a 510(k) Report

What was it cleared against? (5)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K020667Codman Hakim Shunt Systems
Summary page 1
…t Classification Name: Central Nervous System Fluid Shunt and Components Regulation Number: 882.550 C. Predicate Device: Codman Hakim Shunt Systems (K020667) Hakim Micro Programmable Valve System (K980778) Codman Hakim Programmable…
Codman & Shurtleff, Inc.2002—
*K980778Hakim Micro Programmable Valve System
Summary page 1
…nts Regulation Number: 882.550 C. Predicate Device: Codman Hakim Shunt Systems (K020667) Hakim Micro Programmable Valve System (K980778) Codman Hakim Programmable Valve (K974739) Codman Hakim Micro Precision Val…
Johnson & Johnson Professionals, Inc.1998—
*K974739Hakim Programmable Valve System
Summary page 1
…dman Hakim Shunt Systems (K020667) Hakim Micro Programmable Valve System (K980778) Codman Hakim Programmable Valve (K974739) Codman Hakim Micro Precision Valve (K973 774) Codman Hakim Precision Valve…
Johnson & Johnson Professionals, Inc.1998—
*K973774Codman Hakim Micro Precision Valve
Summary page 1
…o Programmable Valve System (K980778) Codman Hakim Programmable Valve (K974739) Codman Hakim Micro Precision Valve (K973 774) Codman Hakim Precision Valve (K944222) D. Device Description: The Codman Hakim Shunt System inco…
Johnson & Johnson Professionals, Inc.1997—
*K944222Codman-Medos Valve Shunt System
Summary page 1
…dman Hakim Programmable Valve (K974739) Codman Hakim Micro Precision Valve (K973 774) Codman Hakim Precision Valve (K944222) D. Device Description: The Codman Hakim Shunt System incorporates all the possible shunt system…
Johnson & Johnson Professionals, Inc.1995—

Also cleared against K020667: 4 other devices →

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 14 years and passes through 2 companies; a new generation was cleared every 3.7 years on median.
  • 1 of the 8 ancestors has a recall of any class.
  • 4 other devices also cite its predicate K020667.

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. 2009, this device’s year, is highlighted.

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—

What is it indicated for?

Codman Hakim Shunt Systems are implantable devices that provide constant intraventricular pressure and drainage of cerebrospinal fluid for the management of hydrocephalus.

Codman. Hakim Shunt Systems are available with or without CODMAN BACTISEAL Catheters, which are intended for use in the treatment of hydrocephalus as a component of a shunt system when draining or shunting of cerebrospinal fluid is indicated.

Codman Hakim Shunt Systems are also available with or without SIPHONGUARD. The SIPHONGUARD device is designed to reduce the potential hazards of excessive lowering of intraventricular pressure (with respect to atmospheric pressure) when a patient is in an upright position.

Indications for use as stated in the FDA summary.

Also cleared against K020667

4 other devices cite the same predicate.

  • K172022CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled)Codman & Shurtleff, Inc. · 20171 recall
  • K122118Hakim Programmable and Precision Valve Shunt SystemCodman & Shurtleff, Inc. · 2012
  • K053350Modification to Codman Hakim Shunt SystemsCodman & Shurtleff, Inc. · 2006
  • K053107Codman Hakim Programmable Valve W/WO SiphonguardCodman & Shurtleff, Inc. · 2006

More from Codman & Shurtleff, Inc.

152 FDA decisions under this applicant name. See the company

  • K193380CERENOVUS Large Bore Catheter; CERENOVUS Aspiration Tubing SetCodman & Shurtleff, Inc. · 2020
  • K191237CERENOVUS Large Bore CatheterCodman & Shurtleff, Inc. · 2019
  • K173192CereLink ICP Sensor Basic Kit, CereLink ICP Sensor Metal Skull Bolt Kit, CereLink ICP Sensor Plastic Skull…Codman & Shurtleff, Inc. · 20171 recall
  • K172537Codman EDS 3 CSF External Drainage System, Codman EDS 3 CSF External Drainage System Collection BagCodman & Shurtleff, Inc. · 2017
  • K172022CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled)Codman & Shurtleff, Inc. · 20171 recall

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/K091346 · printed Nov 4, 2026

Cite this page

510(k) Report. “K091346: Codman Hakim Micro II Valve.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091346

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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