510(k) Report

510(k) · Cleared

Cleared

Codman-Medos Valve Shunt System

K944222510(k) TraditionalCleared Jul 28, 1995332-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

Johnson & Johnson Professionals, Inc. · JXG Shunt, Central Nervous System And Components

Cleared on Jul 28, 1995 after a 332-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1 of the 50 devices in its family, counting itself, has a Class I recall. 49 later devices descend from it.

Decided
Jul 28, 1995
Review
332 days
Class
Class II
Product code
JXG
Recalls
None
Predicates
0

49 later devices descend from it, 8 citing it directly. 1 of the 50 devices in this family, counting this one, has a Class I recall.

Descendants, by year cleared 2017: 2 descendants cleared1997: 1 descendant cleared1998: 2 descendants cleared2012: 3 descendants cleared2006: 3 descendants cleared2009: 2 descendants cleared2011: 3 descendants cleared2002: 4 descendants cleared2022: 1 descendant cleared2024: 2 descendants cleared2015: 3 descendants cleared2000: 1 descendant cleared2004: 5 descendants cleared2005: 2 descendants cleared2018: 3 descendants cleared2023: 1 descendant cleared2025: 1 descendant cleared2007: 1 descendant cleared2020: 1 descendant cleared2008: 2 descendants cleared2016: 1 descendant cleared, 1 with a Class I recall12010: 2 descendants cleared2013: 1 descendant cleared2021: 1 descendant cleared2019: 1 descendant cleared1995200020052010201520202025
  1. This deviceK944222 Codman-Medos Valve Shunt SystemJohnson & Johnson Professionals, Inc. · 1995
  2. Descendant · cites it directly · 42 of its ownK974739 Hakim Programmable Valve SystemJohnson & Johnson Professionals, Inc. · 1998
  3. Descendant · cites it directly · 40 of its ownK973774 Codman Hakim Micro Precision ValveJohnson & Johnson Professionals, Inc. · 1997
  4. Descendant · 2 generations on · 38 of its ownK980778 Hakim Micro Programmable Valve SystemJohnson & Johnson Professionals, Inc. · 1998
  5. Descendant · 2 generations on · 29 of its ownK992465 Sophy SU8 Pressure Adjustable ValveSophysa SA · 2000
  6. Descendant · 2 generations on · 25 of its ownK012052 Medtronic PS Medical Strata Valve, Models 42855, 42865, 92865, 92855Medtronic PS Medical · 2002

Showing 5 of 49 descendants. See all descendants

Descendants cleared per year

1997: 11998: 22000: 12002: 42004: 52005: 22006: 32007: 12008: 22009: 22010: 22011: 32012: 32013: 12015: 32016: 12017: 22018: 32019: 12020: 12021: 12022: 12023: 12024: 22025: 1
1997high 5 (2004) · low 0 (1999)2026

Class I recalls in this family

  • K152700 StrataMR Valves and Shunts4 generations on · 2016

Most influential descendants

Showing 5 of 49 · See all
  • K974739Hakim Programmable Valve SystemJohnson & Johnson Professionals, Inc. · 1998 · cites it directly42descendants
  • K973774Codman Hakim Micro Precision ValveJohnson & Johnson Professionals, Inc. · 1997 · cites it directly40descendants
  • K980778Hakim Micro Programmable Valve SystemJohnson & Johnson Professionals, Inc. · 1998 · 2 generations on38descendants
  • K992465Sophy SU8 Pressure Adjustable ValveSophysa SA · 2000 · 2 generations on29descendants
  • K012052Medtronic PS Medical Strata Valve, Models 42855, 42865, 92865, 92855Medtronic PS Medical · 2002 · 2 generations on25descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K944222Codman-Medos Valve Shunt SystemJohnson & Johnson Professionals, Inc.1995—
+1K974739Hakim Programmable Valve SystemJohnson & Johnson Professionals, Inc.1998—
+1K973774Codman Hakim Micro Precision ValveJohnson & Johnson Professionals, Inc.1997—
+2K980778Hakim Micro Programmable Valve SystemJohnson & Johnson Professionals, Inc.1998—
+2K992465Sophy SU8 Pressure Adjustable ValveSophysa SA2000—
+2K012052Medtronic PS Medical Strata Valve, Models 42855, 42865, 92865, 92855Medtronic PS Medical2002—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
199820
200010
200240
200450
200520
200630
200710
200820
200920
201020
201130
201230
201310
201530
201611
201720
201830
201910
202010
202110
202210
202310
202420
202510
FIG. 1 — Lineage of K944222, 1995–2025Source: 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.

1 device in this family has a Class I recall. 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?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (49)

See all 49

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

NumberDeviceApplicantDecidedDescendants
K974739Hakim Programmable Valve SystemJohnson & Johnson Professionals, Inc.199842
K973774Codman Hakim Micro Precision ValveJohnson & Johnson Professionals, Inc.199740
K020667Codman Hakim Shunt SystemsCodman & Shurtleff, Inc.20028
K053350Modification to Codman Hakim Shunt SystemsCodman & Shurtleff, Inc.20065
K122118Hakim Programmable and Precision Valve Shunt SystemCodman & Shurtleff, Inc.20124
K172022CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled)Codman & Shurtleff, Inc.20173
K102961Holter in-Line Shunt Filter, Holter Cerebral Catheter Reservoir, Accu-Flo Connectors…Codman & Shurtleff, Inc.20110
K091346Codman Hakim Micro II ValveCodman & Shurtleff, Inc.20090

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K152700StrataMR Valves and ShuntsMedtronic Neurosurgery · 2016 · 4 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • Of its descendants, K974739 (Johnson & Johnson Professionals, Inc., 1998) has gone furthest, with 42 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 Johnson & Johnson Professionals, Inc.

206 FDA decisions under this applicant name. See the company

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  • K991413Codman Ethisorb Dura PatchJohnson & Johnson Professionals, Inc. · 2000
  • K991222Codman Microsensor Ventricular Catheter KitJohnson & Johnson Professionals, Inc. · 1999
  • K982379Sundt Slim-Line Aneurysm Clip ApplierJohnson & Johnson Professionals, Inc. · 1998
  • K982812G2 Total Hip System Femoral Stem (11/13 Taper)Johnson & Johnson Professionals, Inc. · 1998

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/K944222 · printed Nov 6, 2026

Cite this page

510(k) Report. “K944222: Codman-Medos Valve 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/K944222

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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