510(k) · Cleared
ClearedClearguard HD End Cap
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pursuit Vascular, Inc. · PEH Hemodialysis Catheter Luer End Cap
Cleared on Dec 16, 2013 after a 244-day review. The FDA summary names its predicate without a number. 1 later device descends from it.
- Decided
- Dec 16, 2013
- Review
- 244 days
- Class
- Class II
- Product code
- PEH
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK131060 Clearguard HD End CapPursuit Vascular, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK180111 ClearGuard HD Antimicrobial Barrier CapPursuit Vascular, Inc. · 2018
Most influential descendants
Showing 1 of 1 · See all- K180111ClearGuard HD Antimicrobial Barrier CapPursuit Vascular, Inc. · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K131060 | Clearguard HD End Cap | Pursuit Vascular, Inc. | 2013 | — |
| +1 | K180111 | ClearGuard HD Antimicrobial Barrier Cap | Pursuit Vascular, Inc. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 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 PEH? 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? (1)
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 |
|---|---|---|---|
| * | — | Boston Scientific Corporation Vaxcel™ Plus Chronic Dialysis Catheter Named without a submission number |
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 |
|---|---|---|---|
| K180111 | ClearGuard HD Antimicrobial Barrier Cap | 2018 | 0 |
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, K180111 (Pursuit Vascular, Inc., 2018) has gone furthest, with 0 descendants of its own.
How does its category compare?
All PEH devicesPEH Hemodialysis Catheter Luer End Cap: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · PEH
1in 2018
2026 to Oct 25, outlined.
Median 510(k) review, days · PEH
Too few PEH 510(k)s in any year since 2007 to give a median.
Recalls per year · PEH
No recall names PEH since 2007.
Adverse event reports per year · PEH
2in 2020
MAUDE reports naming product code PEH, 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 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 7 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
ClearGuard HD is indicated for use as an end cap for use with hemodialysis catheter hubs. The antimicrobial treatment on the ClearGuard HD has been shown to be effective at reducing microbial colonization in hemodialysis catheter hubs against the following microorganisms: Enterococcusfaecium (I/RE), Enterococcusfoecalis (I/RE), Acinetobacter baumannit, Escherichia coli, Staphylococcus aureus (MRSA), Staphylococcus aureus, Staphylococcus epidermidis…
Read the full statement (139 words)
ClearGuard HD is indicated for use as an end cap for use with hemodialysis catheter hubs.
The antimicrobial treatment on the ClearGuard HD has been shown to be effective at reducing microbial colonization in hemodialysis catheter hubs against the following microorganisms: Enterococcusfaecium (I/RE), Enterococcusfoecalis (I/RE), Acinetobacter baumannit, Escherichia coli, Staphylococcus aureus (MRSA), Staphylococcus aureus, Staphylococcus epidermidis (MRSE%, Pseudomonos aeruginoso, Candida olbi cans and Candida parapsilosis and has not been shown to be effective against Condida paratropica/is and Kiebsiella pneumoniae.
The antimicrobial effectiveness was evaluated using in vitro methods, and correlation between in vitro antibacterial activity and any clinical effectiveness has not been tested. The subject device is not intended to be used for the treatment of existing infections. The antimicrobial is only effective within the hub of the catheter, and does not migrate to distal portions of the catheter.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131060 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131060: Clearguard HD End Cap.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131060
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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