510(k) Report

510(k) · Cleared

Cleared

Codman Bactiseal Catheters, Codman Bactiseal Evd Catheter

K102589510(k) SpecialCleared Jan 14, 2011127-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 Jan 14, 2011 as substantially equivalent to K003322 (Codman & Shurtleff, Inc., 2001) and 1 other predicate after a 127-day review. Its family tree reaches back 1 generation to 2001. 4 later devices descend from it.

Decided
Jan 14, 2011
Review
127 days
Class
Class II
Product code
JXG
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K003322 (2001). 2 ancestors in all. 4 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2002: 1 other ancestor2017: 1 descendant cleared2022: 1 descendant cleared2024: 1 descendant cleared2025: 1 descendant clearedK003322 · Codman Bactiseal Catheters · Codman & Shurtleff, Inc. · 2001200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 1 descendant2 generations forward: 2 descendants3 generations forward: 1 descendant K003322 · Codman Bactiseal Catheters · Codman & Shurtleff, Inc. · 20010
  1. Root · 1 generation backK003322 Codman Bactiseal CathetersCodman & Shurtleff, Inc. · 2001
  2. This deviceK102589 Codman Bactiseal Catheters, Codman Bactiseal Evd CatheterCodman & Shurtleff, Inc. · 2011
  3. Descendant · cites it directly · 3 of its ownK172022 CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled)Codman & Shurtleff, Inc. · 2017 · Recalled
  4. Descendant · 2 generations on · 1 of its ownK233445 Bactiseal Catheters; Bactiseal Barium Striped Catheters; Bactiseal…Integra Lifesciences Production Corporation · 2024
  5. Descendant · 3 generations on · 0 of its ownK243531 Codman Libertís Shunt Catheter with Bactiseal and Endexo TechnologyIntegra Lifesciences Production Corporation · 2025
  6. Descendant · 2 generations on · 0 of its ownK221840 Hakim Programmable Valves, Hakim Precision Fixed Pressure ValvesIntegra Lifesciences Production Corporation · 2022

Most influential descendants

Showing 4 of 4 · See all
  • K172022CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled)Codman & Shurtleff, Inc. · 2017 · cites it directly3descendants
  • K233445Bactiseal Catheters; Bactiseal Barium Striped Catheters; Bactiseal Endoscopic…Integra Lifesciences Production Corporation · 2024 · 2 generations on1descendant
  • K243531Codman Libertís Shunt Catheter with Bactiseal and Endexo TechnologyIntegra Lifesciences Production Corporation · 2025 · 3 generations on0descendants
  • K221840Hakim Programmable Valves, Hakim Precision Fixed Pressure ValvesIntegra Lifesciences Production Corporation · 2022 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K003322Codman Bactiseal CathetersCodman & Shurtleff, Inc.2001—
0 (this device)K102589Codman Bactiseal Catheters, Codman Bactiseal Evd CatheterCodman & Shurtleff, Inc.2011—
+1K172022CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled)Codman & Shurtleff, Inc.20171
+2K233445Bactiseal Catheters; Bactiseal Barium Striped Catheters; Bactiseal Endoscopic…Integra Lifesciences Production Corporation2024—
+3K243531Codman Libertís Shunt Catheter with Bactiseal and Endexo TechnologyIntegra Lifesciences Production Corporation2025—
+2K221840Hakim Programmable Valves, Hakim Precision Fixed Pressure ValvesIntegra Lifesciences Production Corporation2022—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200210

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201710
202210
202410
202510
FIG. 1 — Lineage of K102589, 2001–2025Source: 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), 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K003322Codman Bactiseal Catheters
Summary page 1
…Components Regulatory Class: Class 11 per 21 CER § 882.5550 Product Code: JXG C. Predicate Device: CODMAN® BACTISEAL® Catheter Set (K003322) CODMAN® BACTISEAL® EVD Catheter Set (K02 1653) D. Device Description: The CODMAN® BACTISEAL9…
Codman & Shurtleff, Inc.2001—
*K021653Codman Bactiseal Evd Catheter Set
Summary page 1
…Product Code: JXG C. Predicate Device: CODMAN® BACTISEAL® Catheter Set (K003322) CODMAN® BACTISEAL® EVD Catheter Set (K02 1653) D. Device Description: The CODMAN® BACTISEAL9 Catheter Set and CODMAN® BACTISEAL® EVD Cathete…
Codman & Shurtleff, Inc.2002—

Also cleared against K003322: 3 other devices →

What descends from it? (4)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K172022CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled)Codman & Shurtleff, Inc.20173

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?

  • None of the 2 ancestors has a recall.
  • Of its descendants, K172022 (Codman & Shurtleff, Inc., 2017) has gone furthest, with 3 descendants of its own.
  • 3 other devices also cite its predicate K003322.

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. 2011, 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@T BACTISEAL® EVD Catheter Set is indicated for gaining access to the ventricles of the brain and can be used with dimensionally compatible devices for draining cerebrospinal fluid (CSF) and other fluids of similar physical characteristics as a means of reducing intracranial pressure and CSF volume. CODMAN® HAKIM@ BACTISEAL® Ventricular Catheter and Distal Catheter Kit with Bactiseal Shunt System is for use in the treatment of hydrocephalus as a…

Read the full statement (153 words)

Codman@T BACTISEAL® EVD Catheter Set is indicated for gaining access to the ventricles of the brain and can be used with dimensionally compatible devices for draining cerebrospinal fluid (CSF) and other fluids of similar physical characteristics as a means of reducing intracranial pressure and CSF volume.

CODMAN® HAKIM@ BACTISEAL® Ventricular Catheter and Distal Catheter Kit with Bactiseal Shunt System is for use in the treatment of hydrocephalus as a component of a shunt system when draining or shunting of cerebrospinal fluid (CSF) is indicated.

CODMAN® HAKIM® BACTISEAL® Ventricular Catheter with Bactiseal Shunt System is for use in the treatment of hydrocephalus as a component of a shunt system when draining or shunting of cerebrospinal fluid (CSF) is indicated.

CODMAN® HAKIM® BACTISEAL® Distal Catheter Kit with Bactiscal Shunt System is for use in the treatment of hydrocephalus as a component of a shunt system when draining or shunting of cerebrospinal fluid (CSF) is indicated.

Indications for use as stated in the FDA summary.

Also cleared against K003322

3 other devices cite the same predicate.

  • K110560Medtronic Ares Antibiotic-Impregnated CatheterMedtronic Neurosurgery · 20113 recalls
  • K110751Codman Bactiseal Endoscopic Venticular CatheterCodman & Shurtleff, Inc. · 20111 recall
  • K020667Codman Hakim Shunt SystemsCodman & Shurtleff, Inc. · 2002

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/K102589 · printed Nov 5, 2026

Cite this page

510(k) Report. “K102589: Codman Bactiseal Catheters, Codman Bactiseal Evd Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K102589

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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