DualCap IV Pole Strips (Disinfectant Caps for Male Luers)

No FDA recalls found in the data synced 5 Oct 2026.

510(k) Number

K142399 ↗

FDA Product Code

QBP

Device Class

Class II

Regulation

21 CFR Part 880.5440

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Catheter Connections Dualcap Solo

  Class II

  FDA 510(k) K123065 Active Cleared 14 Dec 2012

• Catheter Connections' Dualcap Solo

  Class II

  FDA 510(k) K113842 Active Cleared 27 Jan 2012

• Catheter Connections' Dualcap Duo

  Class II

  FDA 510(k) K112985 Active Cleared 9 Nov 2011

• Catheter Connections Dualcap

  Class II

  FDA 510(k) K093229 Active Cleared 8 Apr 2010

• DualCap

  Class II

  FDA 510(k) K142806 Active Cleared 22 May 2015

• Catheter Connections' Dark Blue Dualcap for Male Luers

  Class II

  FDA 510(k) K123967 Active Cleared 22 Jan 2013

• What are the DualCap IV Pole Strips designed for?

  The DualCap IV Pole Strips are designed as disinfectant caps specifically for male luer connectors, such as needle-free luer access valves on intravenous (IV) lines. They create a physical barrier to contamination while also disinfecting the connector when applied for 30 seconds, ensuring sterile access to IV systems in general hospital settings.

• How are these caps supplied, and are they reusable?

  The DualCap IV Pole Strips are supplied in strips and are intended for single-use only. This design ensures sterility and hygiene compliance, as reuse could compromise the disinfectant properties and barrier protection.

• How long do these caps protect against contamination after application?

  Once applied for the required 30-second disinfection period, these caps provide up to 7 days of contamination protection under normal conditions. This duration helps maintain hygiene standards for IV lines in clinical environments.

• What regulatory approvals do these disinfectant caps hold?

  The DualCap IV Pole Strips are cleared by the FDA under the 510(k) pathway with clearance number K142399. They are classified as a Class II device under the product code QBP (Device Disinfectant) and comply with FDA regulations for general hospital use.

• How should these caps be stored to maintain sterility?

  These caps must be stored and handled according to sterile medical device protocols to preserve their sterility. This includes keeping them in their original packaging until immediate use and avoiding exposure to contaminants or environmental conditions that could compromise their integrity.