Product code QBP
- Device name
- Cap, Device Disinfectant
- Medical specialty
- General Hospital
- Device class
- 2
- Regulation number
- 880.5440
- Review panel
- HO
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Definition
- Disinfect needleless access valves and may act as a physical barrier to contamination if not removed for a set period of time
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252006 | OTTO™ Disinfecting Cap | Icu Medical, Inc. | 2026-03-27 |
| K251592 | SteriHub™ Disinfecting Device and Protective Cover | 1World Vista Medical | 2026-02-11 |
| K223914 | ACTIV™ Cap | Cleansite Medical, Inc. | 2024-04-05 |
| K193190 | BD PureHub Disinfecting Cap | Becton, Dickinson and Company | 2020-11-09 |
| K200299 | Curos Jet Disinfecting Cap | 3M Company | 2020-10-29 |
| K192382 | CapKlenZ | Star Mountain Medical, Inc. | 2020-04-20 |
| K190918 | SwabTip Male Disinfectant Cap | Icu Medical | 2020-03-06 |
| K142806 | DualCap | Catheter Connections, Inc. | 2015-05-22 |
| K140657 | CUROS RED PORT PROTECTOR | Ivera Medical, Inc. | 2014-12-04 |
| K142399 | DualCap IV Pole Strips(Disinfectant Caps for Male Luers) | Catheter Connections, Inc. | 2014-11-19 |
| K130975 | SWABCAP AND SWABFLUSH | Excelsior Medical Corp. | 2013-12-24 |
| K123967 | CATHETER CONNECTIONS' DARK BLUE DUALCAP FOR MALE LUERS | Catheter Connections, Inc. | 2013-01-22 |
| K123065 | CATHETER CONNECTIONS DUALCAP SOLO | Catheter Connections, Inc. | 2012-12-14 |
| K121171 | CUROS TIP | Ivera Medical, Inc. | 2012-11-26 |
| K113842 | CATHETER CONNECTIONS' DUALCAP SOLO | Catheter Connections, Inc. | 2012-01-27 |
| K111992 | CUROS PORT PROTECTOR | Ivera Medical, Inc. | 2012-01-12 |
| K112985 | CATHETER CONNECTIONS' DUALCAP DUO | Catheter Connections, Inc. | 2011-11-09 |
| K110826 | CUROS PORT PROTECTOR | Ivera Medical | 2011-06-23 |
| K093229 | CATHETER CONNECTIONS DUALCAP | Catheter Connections, Inc. | 2010-04-08 |
| K083508 | SWABCAP | Excelsior Medical Corp. | 2009-04-28 |
| K080466 | ALCOHOL PAD | 122 Corporation | 2008-10-21 |
| K080579 | EFFECTIV (TM) CAP | Hospira, Inc. | 2008-09-11 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 30887709097101 | SwabSleeve™ | ICU MEDICAL, INC. | 2024-04-05 |
| 10887709097107 | SwabSleeve™ | ICU MEDICAL, INC. | 2024-04-05 |
| 30612479261656 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2022-11-10 |
| 40612479261639 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2022-11-10 |
| 20612479261628 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2022-11-10 |
| 20612479261642 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2022-11-10 |
| 30887709097828 | SwabTip™ | ICU MEDICAL, INC. | 2021-08-23 |
| 00887709097827 | SwabTip™ | ICU MEDICAL, INC. | 2021-08-23 |
| 00887709082175 | SwabCap™ | ICU MEDICAL, INC. | 2021-07-09 |
| 10887709082158 | SwabCap™ | ICU MEDICAL, INC. | 2021-07-09 |
| 10887709082172 | SwabCap™ | ICU MEDICAL, INC. | 2021-07-09 |
| 00887709082151 | SwabCap™ | ICU MEDICAL, INC. | 2021-07-09 |
| 10884450309978 | DualCap® | Merit Medical Systems, Inc. | 2021-05-17 |
| 20884450309975 | DualCap® | Merit Medical Systems, Inc. | 2021-05-17 |
| 30382903065968 | BD PureHub | BECTON, DICKINSON AND COMPANY | 2020-05-08 |
| 00382903065974 | BD PureHub | BECTON, DICKINSON AND COMPANY | 2020-05-08 |
| 50382903065962 | BD PureHub | BECTON, DICKINSON AND COMPANY | 2020-05-08 |
| 50382903065979 | BD PureHub | BECTON, DICKINSON AND COMPANY | 2020-05-08 |
| 10884450309459 | DualCap® | Merit Medical Systems, Inc. | 2020-01-06 |
| 20884450309456 | DualCap® | Merit Medical Systems, Inc. | 2020-01-06 |
| 20884450309425 | DualCap® | Merit Medical Systems, Inc. | 2019-01-16 |
| 10884450309428 | DualCap® | Merit Medical Systems, Inc. | 2019-01-16 |
| 20884450309364 | DualCap® | Merit Medical Systems, Inc. | 2018-09-28 |
| 20884450309418 | DualCap® | Merit Medical Systems, Inc. | 2018-09-28 |
| 20884450309371 | DualCap® | Merit Medical Systems, Inc. | 2018-09-28 |
| 10884450309367 | DualCap® | Merit Medical Systems, Inc. | 2018-09-28 |
| 10884450309411 | DualCap® | Merit Medical Systems, Inc. | 2018-09-28 |
| 10884450309374 | DualCap® | Merit Medical Systems, Inc. | 2018-09-28 |