510(k) Report

510(k) · Cleared

Cleared

Codman Bactiseal Evd Catheter Set

K021653510(k) TraditionalCleared Jul 29, 200270-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 Jul 29, 2002 after a 70-day review. The FDA summary names its predicate without a number. 8 later devices descend from it.

Decided
Jul 29, 2002
Review
70 days
Class
Class II
Product code
JXG
Recalls
None
Predicates
0

8 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2009: 1 descendant cleared2011: 1 descendant cleared2023: 1 descendant cleared2017: 1 descendant cleared2025: 2 descendants cleared2022: 1 descendant cleared2024: 1 descendant cleared200020052010201520202025
  1. This deviceK021653 Codman Bactiseal Evd Catheter SetCodman & Shurtleff, Inc. · 2002
  2. Descendant · cites it directly · 4 of its ownK102589 Codman Bactiseal Catheters, Codman Bactiseal Evd CatheterCodman & Shurtleff, Inc. · 2011
  3. Descendant · 2 generations on · 3 of its ownK172022 CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled)Codman & Shurtleff, Inc. · 2017 · Recalled
  4. Descendant · cites it directly · 2 of its ownK090348 Codman Bactiseal Evd Catheter Set, Codman Bactiseal Clear Evd…Codman & Shurtleff, Inc. · 2009
  5. Descendant · 3 generations on · 1 of its ownK233445 Bactiseal Catheters; Bactiseal Barium Striped Catheters; Bactiseal…Integra Lifesciences Production Corporation · 2024
  6. Descendant · cites it directly · 1 of its ownK233448 Bactiseal EVD Catheter Sets; Bactiseal Clear EVD Catheter SetIntegra Lifesciences Production Corporation · 2023 · Recalled

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2009: 12011: 12017: 12022: 12023: 12024: 12025: 2
2009high 2 (2025) · low 0 (2010)2026

Most influential descendants

Showing 5 of 8 · See all
  • K102589Codman Bactiseal Catheters, Codman Bactiseal Evd CatheterCodman & Shurtleff, Inc. · 2011 · cites it directly4descendants
  • K172022CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled)Codman & Shurtleff, Inc. · 2017 · 2 generations on3descendants
  • K090348Codman Bactiseal Evd Catheter Set, Codman Bactiseal Clear Evd Catheter SetCodman & Shurtleff, Inc. · 2009 · cites it directly2descendants
  • K233445Bactiseal Catheters; Bactiseal Barium Striped Catheters; Bactiseal Endoscopic…Integra Lifesciences Production Corporation · 2024 · 3 generations on1descendant
  • K233448Bactiseal EVD Catheter Sets; Bactiseal Clear EVD Catheter SetIntegra Lifesciences Production Corporation · 2023 · cites it directly1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K021653Codman Bactiseal Evd Catheter SetCodman & Shurtleff, Inc.2002—
+1K102589Codman Bactiseal Catheters, Codman Bactiseal Evd CatheterCodman & Shurtleff, Inc.2011—
+2K172022CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled)Codman & Shurtleff, Inc.20171
+1K090348Codman Bactiseal Evd Catheter Set, Codman Bactiseal Clear Evd Catheter SetCodman & Shurtleff, Inc.2009—
+3K233445Bactiseal Catheters; Bactiseal Barium Striped Catheters; Bactiseal Endoscopic…Integra Lifesciences Production Corporation2024—
+1K233448Bactiseal EVD Catheter Sets; Bactiseal Clear EVD Catheter SetIntegra Lifesciences Production Corporation20233

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
201110
201710
202210
202310
202410
202520
FIG. 1 — Lineage of K021653, 2002–2025Source: 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? (3)

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
*—Codman BACTISEAL Catheters
Named without a submission number
—
*—Codman External Drainage Ventricular Catheter Set
Named without a submission number
—
*—Cook Inc. SPECTRUM Ventricular Catheter
Named without a submission number
—

What descends from it? (8)

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

NumberDeviceApplicantDecidedDescendants
K102589Codman Bactiseal Catheters, Codman Bactiseal Evd CatheterCodman & Shurtleff, Inc.20114
K090348Codman Bactiseal Evd Catheter Set, Codman Bactiseal Clear Evd Catheter SetCodman & Shurtleff, Inc.20092
K233448Bactiseal EVD Catheter Sets; Bactiseal Clear EVD Catheter SetIntegra Lifesciences Production Corporation20231

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?

  • Of its descendants, K102589 (Codman & Shurtleff, Inc., 2011) has gone furthest, with 4 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—

What is it indicated for?

The Codman BACTISEALTM 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.

Indications for use as stated in the FDA summary.

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/K021653 · printed Nov 6, 2026

Cite this page

510(k) Report. “K021653: Codman Bactiseal Evd Catheter Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K021653

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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