510(k) · Cleared

Cleared

ClearGuard HD Antimicrobial Barrier Cap

K180111510(k) TraditionalCleared May 25, 2018129-day reviewClass II21 CFR 876.5540

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Pursuit Vascular, Inc. · PEH Hemodialysis Catheter Luer End Cap

Cleared on May 25, 2018 as substantially equivalent to K131060 (Pursuit Vascular, Inc., 2013) after a 129-day review. Its family tree reaches back 1 generation to 2013.

Decided: May 25, 2018
Review: 129 days
Class: Class II
Product code: PEH
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K131060 (2013). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK131060 Clearguard HD End CapPursuit Vascular, Inc. · 2013
This deviceK180111 ClearGuard HD Antimicrobial Barrier CapPursuit Vascular, Inc. · 2018

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K131060	Clearguard HD End Cap	Pursuit Vascular, Inc.	2013	—
0 (this device)	K180111	ClearGuard HD Antimicrobial Barrier Cap	Pursuit Vascular, Inc.	2018	—

FIG. 1 — Lineage of K180111, 2013–2018Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K131060	Clearguard HD End Cap Summary page 4 …Access Device and Accessories Product Code PEH; Hemodialysis Catheter Luer End Cap Device Class II Predicate Devices K131060 ClearGuard HD End Cap Device Description The ClearGuard HD Antimicrobial Barrier Cap (hereinafter also referred to as the ClearG…	Pursuit Vascular, Inc.	2013	—

What descends from it?

No later submission names this one as a predicate yet.

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?

Its one ancestor has no recall.

How does its category compare?

All PEH devices

PEH Hemodialysis Catheter Luer End Cap: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.

FDA decisions per year · PEH

1in 2018

2007high 1 (2013) · low 0 (2007)2026

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

2007high 7 (2019) · low 0 (2007)2025

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	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	0	—	0
2010	0	—	0
2011	0	—	0
2012	0	—	0
2013	1	—	0
2014	0	—	0
2015	0	—	0
2016	0	—	0
2017	0	—	0
2018	1	—	0
2019	0	—	7
2020	0	—	2
2021	0	—	0
2022	0	—	0
2023	0	—	0
2024	0	—	0
2025	0	—	0
2026	0	—	—

What is it indicated for?

ClearGuard HD Antimicrobial Barrier Cap is indicated for use with hemodialysis catheter hubs. Using in vitro methods, the antimicrobial treatment on the ClearGuard HD Antimicrobial Barrier Cap has been shown to be effective at reducing microbial colonization in hemodialysis catheter hubs against the following microorganisms: Enterococcus faecium (VRE), Enterococcus faecalis (VRE), Acinetobacter baumannii, Escherichia coli, Staphylococcus aureus (MRSA)…

Read the full statement (235 words)

ClearGuard HD Antimicrobial Barrier Cap is indicated for use with hemodialysis catheter hubs.

Using in vitro methods, the antimicrobial treatment on the ClearGuard HD Antimicrobial Barrier Cap has been shown to be effective at reducing microbial colonization in hemodialysis catheter hubs against the following microorganisms: Enterococcus faecium (VRE), Enterococcus faecalis (VRE), Acinetobacter baumannii, Escherichia coli, Staphylococcus aureus (MRSA), Staphylococcus aureus, Staphylococcus epidermidis (MRSE), Pseudomonas aeruginosa, Candida albicans and Candida parapsilosis and has not been shown to be effective against Candida paratropicalis and Klebsiella pneumoniae.

Using post-market clinical surveillance data, use of the ClearGuard HD Antimicrobial Barrier Cap has been shown to reduce the incidence of central-line associated bloodstream infections (CLABSI) in hemodialysis patients with catheters. Note: CLABSI was defined as a positive blood culture (PBC) not related to an alternative source of infection per the National Healthcare Safety Network (NHSN) surveillance definition. Alternative sources were excluded if dialysis sites attributed the PBC to vascular access on the dialysis event form. The actual reduction in CLABSI rates may be less substantial as the evaluation for alternative PBC sources was not pre-specified, nor standardized between patients and clinical sites, and supplemental data evaluating for alternative sources were not available for review.

The subject device is not intended to be used for the treatment of existing infections. The antimicrobial is only present 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/K180111 · printed Nov 6, 2026

Cite this page

510(k) Report. “K180111: ClearGuard HD Antimicrobial Barrier Cap.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180111

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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