510(k) · Cleared
Recalled · Class II · 2024Bactiseal EVD Catheter Sets; Bactiseal Clear EVD Catheter Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Integra Lifesciences Production Corporation · JXG Shunt, Central Nervous System And Components
Cleared on Dec 19, 2023 as substantially equivalent to K021653 (Codman & Shurtleff, Inc., 2002) and 1 other predicate after a 60-day review. Its family tree reaches back 2 generations to 2002. 1 later device descends from it. It has been recalled 3 times.
- Decided
- Dec 19, 2023
- Review
- 60 days
- Class
- Class II
- Product code
- JXG
- Recalls
- 3
- Predicates
- 2
Its longest line of descent runs back 2 generations to K021653 (2002). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK021653 Codman Bactiseal Evd Catheter SetCodman & Shurtleff, Inc. · 2002
- 1 generation backK090348 Codman Bactiseal Evd Catheter Set, Codman Bactiseal Clear Evd…Codman & Shurtleff, Inc. · 2009
- This deviceK233448 Bactiseal EVD Catheter Sets; Bactiseal Clear EVD Catheter SetIntegra Lifesciences Production Corporation · 2023
- Descendant · cites it directly · 0 of its ownK243552 Codman Libertís™ 1.5 mm EVD Catheter with Bactiseal® and Endexo®…Integra Lifesciences Production Corporation · 2025
Most influential descendants
Showing 1 of 1 · See all- K243552Codman Libertís™ 1.5 mm EVD Catheter with Bactiseal® and Endexo® Technology with Luer…Integra Lifesciences Production Corporation · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K021653 | Codman Bactiseal Evd Catheter Set | Codman & Shurtleff, Inc. | 2002 | — |
| −1 | K090348 | Codman Bactiseal Evd Catheter Set, Codman Bactiseal Clear Evd Catheter Set | Codman & Shurtleff, Inc. | 2009 | — |
| 0 (this device) | K233448 | Bactiseal EVD Catheter Sets; Bactiseal Clear EVD Catheter Set | Integra Lifesciences Production Corporation | 2023 | — |
| +1 | K243552 | Codman Libertís™ 1.5 mm EVD Catheter with Bactiseal® and Endexo® Technology… | Integra Lifesciences Production Corporation | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 0 |
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 K243531 Codman Libertís Shunt Catheter with Bactiseal…score 11.9 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K021653 | Codman Bactiseal Evd Catheter SetSummary page 5…II Product Code JXG 807.92(a) (3) Predicate Information Predicate Device Bactiseal EVD Catheter Set: K021653 Bactiseal EVD Catheter Set and Bactiseal Clear EVD Catheter… | 2002 |
| * | K090348 | Codman Bactiseal Evd Catheter Set, Codman Bactiseal Clear Evd Catheter SetSummary page 5…seal EVD Catheter Set: K021653 Bactiseal EVD Catheter Set and Bactiseal Clear EVD Catheter Set: K090348 807.92(a) (4) Device Description The Bactiseal EVD Catheter Sets and Bactiseal Clear EVD Catheter Set include a ventricular ca… | 2009 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K243552 | Codman Libertís™ 1.5 mm EVD Catheter with Bactiseal® and Endexo® Technology with Luer… | 2025 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 7, 2024 | Class II | Z-2138-2024 | Process control | Defect in the external sterile packaging (pouch) leading to a gap or/and weakness of the seal may compromise the product sterility. |
| May 7, 2024 | Class II | Z-2136-2024 | Process control | Defect in the external sterile packaging (pouch) leading to a gap or/and weakness of the seal that may compromise the product sterility. |
| May 7, 2024 | Class II | Z-2137-2024 | Process control | Defect in the external sterile packaging (pouch) leading to a gap or/and weakness of the seal may compromise the product sterility. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 2 companies; a new generation was cleared every 14.8 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K243552 (Integra Lifesciences Production Corporation, 2025) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K021653.
How does its category compare?
All JXG devicesJXG Shunt, Central Nervous System And Components: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · JXG
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JXG
255in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JXG
3in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JXG
1,198in 2025
MAUDE reports naming product code JXG, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 3 | 184 | 0 | 649 |
| 2008 | 6 | 60 | 1 | 630 |
| 2009 | 5 | 106 | 30 | 629 |
| 2010 | 3 | 30 | 0 | 812 |
| 2011 | 7 | 136 | 5 | 787 |
| 2012 | 3 | 78 | 1 | 977 |
| 2013 | 3 | 108 | 14 | 1,004 |
| 2014 | 0 | — | 6 | 1,251 |
| 2015 | 6 | 276 | 0 | 984 |
| 2016 | 6 | 143 | 0 | 1,091 |
| 2017 | 7 | 90 | 1 | 1,335 |
| 2018 | 6 | 102 | 0 | 1,484 |
| 2019 | 4 | 101 | 0 | 1,295 |
| 2020 | 2 | — | 8 | 1,206 |
| 2021 | 1 | — | 0 | 1,467 |
| 2022 | 4 | 101 | 0 | 1,329 |
| 2023 | 5 | 134 | 2 | 1,221 |
| 2024 | 3 | 90 | 3 | 1,214 |
| 2025 | 8 | 255 | 0 | 1,198 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
The Bactiseal EVD Catheter and Bactiseal Clear EVD Catheter sets are 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.
https://510kreport.com/device/K233448 · printed Nov 6, 2026
Cite this page
510(k) Report. “K233448: Bactiseal EVD Catheter Sets; Bactiseal Clear 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/K233448
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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