Browse hierarchy: [General Hospital (HO)](/submissions/HO) → [Subpart F — General Hospital and Personal Use Therapeutic Devices](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices) → [21 CFR 880.5440](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/880.5440) → QBP — Cap, Device Disinfectant # QBP · Cap, Device Disinfectant _General Hospital · 21 CFR 880.5440 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/QBP ## Overview - **Product Code:** QBP - **Device Name:** Cap, Device Disinfectant - **Regulation:** [21 CFR 880.5440](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/880.5440) - **Device Class:** 2 - **Review Panel:** [General Hospital](/submissions/HO) ## Identification An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container. ## Classification Rationale Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9. ## Special Controls *Classification.* Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9. ## Recent Cleared Devices (20 of 22) Showing 20 most recent of 22 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K252006](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/QBP/K252006.md) | OTTO™ Disinfecting Cap | Icu Medical, Inc. | Mar 27, 2026 | SESE | | [K251592](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/QBP/K251592.md) | SteriHub™ Disinfecting Device and Protective Cover | 1World Vista Medical | Feb 11, 2026 | SESE | | [K223914](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/QBP/K223914.md) | ACTIV™ Cap | Cleansite Medical, Inc. | Apr 5, 2024 | SESE | | [K193190](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/QBP/K193190.md) | BD PureHub Disinfecting Cap | Becton, Dickinson and Company | Nov 9, 2020 | SESE | | [K200299](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/QBP/K200299.md) | Curos Jet Disinfecting Cap | 3M Company | Oct 29, 2020 | SESE | | [K192382](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/QBP/K192382.md) | CapKlenZ | Star Mountain Medical, Inc. | Apr 20, 2020 | SESE | | [K190918](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/QBP/K190918.md) | SwabTip Male Disinfectant Cap | Icu Medical | Mar 6, 2020 | SESE | | [K142806](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/QBP/K142806.md) | DualCap | Catheter Connections, Inc. | May 22, 2015 | SESE | | [K140657](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/QBP/K140657.md) | CUROS RED PORT PROTECTOR | Ivera Medical, Inc. | Dec 4, 2014 | SESE | | [K142399](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/QBP/K142399.md) | DualCap IV Pole Strips(Disinfectant Caps for Male Luers) | Catheter Connections, Inc. | Nov 19, 2014 | SESE | | [K130975](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/QBP/K130975.md) | SWABCAP AND SWABFLUSH | Excelsior Medical Corp. | Dec 24, 2013 | SESE | | [K123967](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/QBP/K123967.md) | CATHETER CONNECTIONS' DARK BLUE DUALCAP FOR MALE LUERS | Catheter Connections, Inc. | Jan 22, 2013 | SESE | | [K123065](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/QBP/K123065.md) | CATHETER CONNECTIONS DUALCAP SOLO | Catheter Connections, Inc. | Dec 14, 2012 | SESE | | [K121171](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/QBP/K121171.md) | CUROS TIP | Ivera Medical, Inc. | Nov 26, 2012 | SESE | | [K113842](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/QBP/K113842.md) | CATHETER CONNECTIONS' DUALCAP SOLO | Catheter Connections, Inc. | Jan 27, 2012 | SESE | | [K111992](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/QBP/K111992.md) | CUROS PORT PROTECTOR | Ivera Medical, Inc. | Jan 12, 2012 | SESE | | [K112985](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/QBP/K112985.md) | CATHETER CONNECTIONS' DUALCAP DUO | Catheter Connections, Inc. | Nov 9, 2011 | SESE | | [K110826](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/QBP/K110826.md) | CUROS PORT PROTECTOR | Ivera Medical | Jun 23, 2011 | SESE | | [K093229](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/QBP/K093229.md) | CATHETER CONNECTIONS DUALCAP | Catheter Connections, Inc. | Apr 8, 2010 | SESE | | [K083508](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/QBP/K083508.md) | SWABCAP | Excelsior Medical Corp. | Apr 28, 2009 | SESE | ## Top Applicants - Catheter Connections, Inc. — 7 clearances - Ivera Medical, Inc. — 3 clearances - Excelsior Medical Corp. — 2 clearances - 122 Corporation — 1 clearance - 1World Vista Medical — 1 clearance --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/QBP](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/QBP) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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