QBP — Cap, Device Disinfectant Class II
FDA product code QBP covers "Cap, Device Disinfectant", a Class II medical device regulated under 21 CFR 880.5440. Submissions are reviewed by the General Hospital panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- QBP
- Device Class
- Class II
- Regulation Number
- 880.5440
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General Hospital
- Implant
- No
Definition
Disinfect needleless access valves and may act as a physical barrier to contamination if not removed for a set period of time
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K252006 | icu medical | OTTO Disinfecting Cap | March 27, 2026 |
| K251592 | 1world vista medical | SteriHub Disinfecting Device and Protective Cover | February 11, 2026 |
| K223914 | cleansite medical | ACTIV Cap | April 5, 2024 |
| K193190 | becton, dickinson and | BD PureHub Disinfecting Cap | November 9, 2020 |
| K200299 | 3m | Curos Jet Disinfecting Cap | October 29, 2020 |
| K192382 | star mountain medical | CapKlenZ | April 20, 2020 |
| K190918 | icu medical | SwabTip Male Disinfectant Cap | March 6, 2020 |
| K142806 | catheter connections | DualCap | May 22, 2015 |
| K140657 | ivera medical | CUROS RED PORT PROTECTOR | December 4, 2014 |
| K142399 | catheter connections | DualCap IV Pole Strips(Disinfectant Caps for Male Luers) | November 19, 2014 |
| K130975 | excelsior medical | SWABCAP AND SWABFLUSH | December 24, 2013 |
| K123967 | catheter connections | CATHETER CONNECTIONS' DARK BLUE DUALCAP FOR MALE LUERS | January 22, 2013 |
| K123065 | catheter connections | CATHETER CONNECTIONS DUALCAP SOLO | December 14, 2012 |
| K121171 | ivera medical | CUROS TIP | November 26, 2012 |
| K113842 | catheter connections | CATHETER CONNECTIONS' DUALCAP SOLO | January 27, 2012 |
| K111992 | ivera medical | CUROS PORT PROTECTOR | January 12, 2012 |
| K112985 | catheter connections | CATHETER CONNECTIONS' DUALCAP DUO | November 9, 2011 |
| K110826 | ivera medical | CUROS PORT PROTECTOR | June 23, 2011 |
| K093229 | catheter connections | CATHETER CONNECTIONS DUALCAP | April 8, 2010 |
| K083508 | excelsior medical | SWABCAP | April 28, 2009 |