510(k) · Cleared
Recalled · Class II · 2021Codman Bactiseal Barium Striped Catheters
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Codman & Shurtleff, Inc. · HCA Catheter, Ventricular
Cleared on May 14, 2003 after a 35-day review. The FDA summary names its predicate without a number. 5 later devices descend from it. It has been recalled once.
- Decided
- May 14, 2003
- Review
- 35 days
- Class
- Class II
- Product code
- HCA
- Recalls
- 1
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK031123 Codman Bactiseal Barium Striped CathetersCodman & Shurtleff, Inc. · 2003
- Descendant · cites it directly · 2 of its ownK090348 Codman Bactiseal Evd Catheter Set, Codman Bactiseal Clear Evd…Codman & Shurtleff, Inc. · 2009
- Descendant · cites it directly · 1 of its ownK233445 Bactiseal Catheters; Bactiseal Barium Striped Catheters; Bactiseal…Integra Lifesciences Production Corporation · 2024
- Descendant · 2 generations on · 1 of its ownK233448 Bactiseal EVD Catheter Sets; Bactiseal Clear EVD Catheter SetIntegra Lifesciences Production Corporation · 2023 · Recalled
- Descendant · 2 generations on · 0 of its ownK243531 Codman Libertís Shunt Catheter with Bactiseal and Endexo TechnologyIntegra Lifesciences Production Corporation · 2025
- Descendant · 3 generations on · 0 of its ownK243552 Codman Libertís™ 1.5 mm EVD Catheter with Bactiseal® and Endexo®…Integra Lifesciences Production Corporation · 2025
Most influential descendants
Showing 5 of 5 · See all- 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 · cites it directly1descendant
- K233448Bactiseal EVD Catheter Sets; Bactiseal Clear EVD Catheter SetIntegra Lifesciences Production Corporation · 2023 · 2 generations on1descendant
- K243531Codman Libertís Shunt Catheter with Bactiseal and Endexo TechnologyIntegra Lifesciences Production Corporation · 2025 · 2 generations on0descendants
- K243552Codman Libertís™ 1.5 mm EVD Catheter with Bactiseal® and Endexo® Technology with Luer…Integra Lifesciences Production Corporation · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K031123 | Codman Bactiseal Barium Striped Catheters | Codman & Shurtleff, Inc. | 2003 | — |
| +1 | K090348 | Codman Bactiseal Evd Catheter Set, Codman Bactiseal Clear Evd Catheter Set | Codman & Shurtleff, Inc. | 2009 | — |
| +1 | K233445 | Bactiseal Catheters; Bactiseal Barium Striped Catheters; Bactiseal Endoscopic… | Integra Lifesciences Production Corporation | 2024 | — |
| +2 | K233448 | Bactiseal EVD Catheter Sets; Bactiseal Clear EVD Catheter Set | Integra Lifesciences Production Corporation | 2023 | 3 |
| +2 | K243531 | Codman Libertís Shunt Catheter with Bactiseal and Endexo Technology | Integra Lifesciences Production Corporation | 2025 | — |
| +3 | K243552 | Codman Libertís™ 1.5 mm EVD Catheter with Bactiseal® and Endexo® Technology… | Integra Lifesciences Production Corporation | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 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 HCA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | Codman BACTISEAL Catheters Named without a submission number | |
| * | — | Uni-Shunt Catheters with Elliptical Reservoir Named without a submission number | |
| * | — | CODMAN HAKIM Shunt Systems Named without a submission number |
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 17, 2021 | Class II | Z-1354-2021 | Labeling Change Control | Incorrect labeling, Catheter did not have the required holes and markings |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K090348 (Codman & Shurtleff, Inc., 2009) has gone furthest, with 2 descendants of its own.
How does its category compare?
All HCA devicesHCA Catheter, Ventricular: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HCA
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · HCA
Too few HCA 510(k)s in any year since 2007 to give a median.
Recalls per year · HCA
No recall names HCA since 2007.
Adverse event reports per year · HCA
1in 2021
MAUDE reports naming product code HCA, 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 | 0 | — | 0 | 8 |
| 2008 | 0 | — | 0 | 3 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 4 |
| 2011 | 0 | — | 0 | 19 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 1 | — | 0 | 3 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Codman BACTISEAL Barium Striped Catheters are intended 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.
https://510kreport.com/device/K031123 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031123: Codman Bactiseal Barium Striped Catheters.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031123
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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