Curos Jet Disinfecting Cap
FDA 510(k)Class II (US FDA 510(k))
by 3m Company
Identifiers
- 510(k) Number
- K200299 FDA 510(k)
- FDA Product Code
- QBP FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.5440 FDA 510(k)
- Regulation Number
- 880.5440 FDA 510(k)
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Curos Jet Disinfecting Cap is a device classified as a Device Disinfectant and Cap, designed to disinfect needleless connectors. It delivers a disinfecting solution to eliminate microbial contamination on connector surfaces, reducing the risk of infection during medical procedures. The cap contains 70% isopropyl alcohol (IPA) to achieve rapid disinfection within one minute of application.
This single-use device is applied by peeling a foil strip and twisting the cap onto the connector, providing protection against contamination for up to seven days if left in place. Supplied in sterile packaging, it is intended for use in general hospital settings. The device holds an FDA 510(k) clearance under the classification of Class II medical devices, adhering to regulatory standards for disinfecting caps in healthcare environments.
Frequently asked questions
What is the Curos Jet Disinfecting Cap used for?
The Curos Jet Disinfecting Cap is designed to eliminate microbial contamination on needleless connectors in healthcare settings. It delivers a disinfecting solution containing 70% isopropyl alcohol (IPA) to rapidly disinfect the connector surface within one minute, helping to reduce the risk of infection during medical procedures. This is particularly useful in general hospital environments where maintaining sterile conditions is critical.
How is the Curos Jet Disinfecting Cap supplied and prepared for use?
The device is supplied in sterile packaging, ensuring it is ready for immediate use upon opening. To prepare it, you peel a foil strip on the cap and then twist it onto the needleless connector. This simple application process ensures the disinfecting solution is applied directly to the connector surface.
Is the Curos Jet Disinfecting Cap single-use or reusable?
The Curos Jet Disinfecting Cap is a single-use device. After application, it should be discarded to maintain sterility and prevent cross-contamination. This design aligns with best practices for infection control in medical settings.
How long does the disinfecting protection last once the cap is applied?
Once the Curos Jet Disinfecting Cap is applied to a needleless connector, it provides protection against contamination for up to seven days if left in place. This extended protection helps maintain a sterile environment during prolonged medical procedures or patient care.
What regulatory approval does the Curos Jet Disinfecting Cap hold?
The Curos Jet Disinfecting Cap holds an FDA 510(k) clearance, classified as a Class II medical device. This clearance confirms that the device meets regulatory standards for disinfecting caps used in healthcare environments, specifically for needleless connectors in general hospital settings.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: PDF Curos Jet, 3M™ Curos Jet™ Disinfecting Cap for Needleless Connectors, CFJ Series, Curos | 3M United States, 3M Port Protectors | 3M United States
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K200299 | Class II | Active |
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Manufacturer
- Manufacturer
- 3m Company
Sources (1)
- FDA 510(k) K200299 24 fields · synced Oct 1, 2026