QBP · Cap, Device Disinfectant
General Hospital · 21 CFR 880.5440 · Class 2
Overview
| Product Code | QBP |
|---|---|
| Device Name | Cap, Device Disinfectant |
| Regulation | 21 CFR 880.5440 |
| Device Class | Class 2 |
| Review Panel | General Hospital |
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 | OTTO Disinfecting Cap | Icu Medical, Inc. | Mar 27, 2026 | SESE |
| K251592 | SteriHub Disinfecting Device and Protective Cover | 1World Vista Medical | Feb 11, 2026 | SESE |
| K223914 | ACTIV Cap | Cleansite Medical, Inc. | Apr 5, 2024 | SESE |
| K193190 | BD PureHub Disinfecting Cap | Becton, Dickinson and Company | Nov 9, 2020 | SESE |
| K200299 | Curos Jet Disinfecting Cap | 3M Company | Oct 29, 2020 | SESE |
| K192382 | CapKlenZ | Star Mountain Medical, Inc. | Apr 20, 2020 | SESE |
| K190918 | SwabTip Male Disinfectant Cap | Icu Medical | Mar 6, 2020 | SESE |
| K142806 | DualCap | Catheter Connections, Inc. | May 22, 2015 | SESE |
| K140657 | CUROS RED PORT PROTECTOR | Ivera Medical, Inc. | Dec 4, 2014 | SESE |
| K142399 | DualCap IV Pole Strips(Disinfectant Caps for Male Luers) | Catheter Connections, Inc. | Nov 19, 2014 | SESE |
| K130975 | SWABCAP AND SWABFLUSH | Excelsior Medical Corp. | Dec 24, 2013 | SESE |
| K123967 | CATHETER CONNECTIONS' DARK BLUE DUALCAP FOR MALE LUERS | Catheter Connections, Inc. | Jan 22, 2013 | SESE |
| K123065 | CATHETER CONNECTIONS DUALCAP SOLO | Catheter Connections, Inc. | Dec 14, 2012 | SESE |
| K121171 | CUROS TIP | Ivera Medical, Inc. | Nov 26, 2012 | SESE |
| K113842 | CATHETER CONNECTIONS' DUALCAP SOLO | Catheter Connections, Inc. | Jan 27, 2012 | SESE |
| K111992 | CUROS PORT PROTECTOR | Ivera Medical, Inc. | Jan 12, 2012 | SESE |
| K112985 | CATHETER CONNECTIONS' DUALCAP DUO | Catheter Connections, Inc. | Nov 9, 2011 | SESE |
| K110826 | CUROS PORT PROTECTOR | Ivera Medical | Jun 23, 2011 | SESE |
| K093229 | CATHETER CONNECTIONS DUALCAP | Catheter Connections, Inc. | Apr 8, 2010 | SESE |
| K083508 | 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
