Cap, Device Disinfectant
The Cap, Device Disinfectant is a device used to disinfect needleless access valves on intravenous lines and may act as a physical barrier to contamination if left in place for a set period of time, intended to reduce the risk of catheter-related bloodstream infections. It is classified as a Class 2 device under regulation 880.5440, requiring 510(k) premarket notification, and falls within the General Hospital (HO) medical specialty. The product code is QBP. It is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- QBP
- Device Class
- FDA class 2
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Review Panel
- HO
- Submission Type
- 1
Device Characteristics
Definition
Disinfect needleless access valves and may act as a physical barrier to contamination if not removed for a set period of time
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 22 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K252006 | OTTO Disinfecting Cap | Mar 27, 2026 | Substantially Equivalent | Icu Medical, Inc. |
| K251592 | SteriHub Disinfecting Device and Protective Cover | Feb 11, 2026 | Substantially Equivalent | 1World Vista Medical |
| K223914 | ACTIV Cap | Apr 05, 2024 | Substantially Equivalent | Cleansite Medical, Inc. |
| K193190 | BD PureHub Disinfecting Cap | Nov 09, 2020 | Substantially Equivalent | Becton, Dickinson and Company |
| K200299 | Curos Jet Disinfecting Cap | Oct 29, 2020 | Substantially Equivalent | 3M Company |
| K192382 | CapKlenZ | Apr 20, 2020 | Substantially Equivalent | Star Mountain Medical, Inc. |
| K190918 | SwabTip Male Disinfectant Cap | Mar 06, 2020 | Substantially Equivalent | Icu Medical |
| K142806 | DualCap | May 22, 2015 | Substantially Equivalent | Catheter Connections, Inc. |
| K140657 | CUROS RED PORT PROTECTOR | Dec 04, 2014 | Substantially Equivalent | Ivera Medical, Inc. |
| K142399 | DualCap IV Pole Strips(Disinfectant Caps for Male Luers) | Nov 19, 2014 | Substantially Equivalent | Catheter Connections, Inc. |
| K130975 | SWABCAP AND SWABFLUSH | Dec 24, 2013 | Substantially Equivalent | Excelsior Medical Corp. |
| K123967 | CATHETER CONNECTIONS' DARK BLUE DUALCAP FOR MALE LUERS | Jan 22, 2013 | Substantially Equivalent | Catheter Connections, Inc. |
| K123065 | CATHETER CONNECTIONS DUALCAP SOLO | Dec 14, 2012 | Substantially Equivalent | Catheter Connections, Inc. |
| K121171 | CUROS TIP | Nov 26, 2012 | Substantially Equivalent | Ivera Medical, Inc. |
| K113842 | CATHETER CONNECTIONS' DUALCAP SOLO | Jan 27, 2012 | Substantially Equivalent | Catheter Connections, Inc. |
| K111992 | CUROS PORT PROTECTOR | Jan 12, 2012 | Substantially Equivalent | Ivera Medical, Inc. |
| K112985 | CATHETER CONNECTIONS' DUALCAP DUO | Nov 09, 2011 | Substantially Equivalent | Catheter Connections, Inc. |
| K110826 | CUROS PORT PROTECTOR | Jun 23, 2011 | Substantially Equivalent | Ivera Medical |
| K093229 | CATHETER CONNECTIONS DUALCAP | Apr 08, 2010 | Substantially Equivalent | Catheter Connections, Inc. |
| K083508 | SWABCAP | Apr 28, 2009 | Substantially Equivalent | Excelsior Medical Corp. |
| K080466 | ALCOHOL PAD | Oct 21, 2008 | Substantially Equivalent | 122 Corporation |
| K080579 | EFFECTIV (TM) CAP | Sep 11, 2008 | Substantially Equivalent | Hospira, Inc. |
FEI Numbers
This FDA classification entry is associated with 30 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 30 registration numbers. Click on an entry to view related FDA registrations.