Cap, Device Disinfectant
FDA product code QBP · Class II (moderate risk) · 21 CFR 880.5440 · General Hospital
Disinfect needleless access valves and may act as a physical barrier to contamination if not removed for a set period of time
22510(k) clearances
0PMA approvals
2recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252006 | OTTO Disinfecting CapQBP · Traditional | Icu Medical, Inc. | 03/27/2026SE |
| K251592 | SteriHub Disinfecting Device and Protective CoverQBP · Traditional | 1World Vista Medical | 02/11/2026SE |
| K223914 | ACTIV CapQBP · Traditional | Cleansite Medical, Inc. | 04/05/2024SE |
| K193190 | BD PureHub Disinfecting CapQBP · Traditional | Becton, Dickinson and Company | 11/09/2020SE |
| K200299 | Curos Jet Disinfecting CapQBP · Traditional | 3M Company | 10/29/2020SE |
| K192382 | CapKlenZQBP · Traditional | Star Mountain Medical, Inc. | 04/20/2020SE |
| K190918 | SwabTip Male Disinfectant CapQBP · Traditional | Icu Medical | 03/06/2020SE |
| K142806 | DualCapQBP · Traditional | Catheter Connections, Inc. | 05/22/2015SE |
| K140657 | Curos Red Port ProtectorQBP · Traditional | Ivera Medical, Inc. | 12/04/2014SE |
| K142399 | DualCap IV Pole Strips(Disinfectant Caps for Male Luers)QBP · Traditional | Catheter Connections, Inc. | 11/19/2014SE |
| K130975 | Swabcap and SwabflushQBP · Traditional | Excelsior Medical Corp. | 12/24/2013SE |
| K123967 | Catheter Connections' Dark Blue Dualcap for Male LuersQBP · Special | Catheter Connections, Inc. | 01/22/2013SE |
| K123065 | Catheter Connections Dualcap SoloQBP · Special | Catheter Connections, Inc. | 12/14/2012SE |
| K121171 | Curos TipQBP · Traditional | Ivera Medical, Inc. | 11/26/2012SE |
| K113842 | Catheter Connections' Dualcap SoloQBP · Special | Catheter Connections, Inc. | 01/27/2012SE |
| K111992 | Curos Port ProtectorQBP · Traditional | Ivera Medical, Inc. | 01/12/2012SE |
| K112985 | Catheter Connections' Dualcap DuoQBP · Special | Catheter Connections, Inc. | 11/09/2011SE |
| K110826 | Curos Port ProtectorQBP · Abbreviated | Ivera Medical | 06/23/2011SE |
| K093229 | Catheter Connections DualcapQBP · Traditional | Catheter Connections, Inc. | 04/08/2010SE |
| K083508 | SwabcapQBP · Traditional | Excelsior Medical Corp. | 04/28/2009SE |
| K080466 | Alcohol PadQBP · Traditional | 122 Corporation | 10/21/2008SE |
| K080579 | Effectiv (TM) CapQBP · Traditional | Hospira, Inc. | 09/11/2008SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2199-2025 Class II | SwabFlush Prefilled Syringe with ICU Medical SwabCaps, 10mL Model no. EMZE010301SwabFlush syringes are affected by the ICU Medical recall of their SwabCap Disinfecting Cap due to a… | MEDLINE INDUSTRIES, LP - Northfield | 06/16/2025Open, Classified |
| Z-2116-2025 Class II | SwabCap Disinfecting Cap for Needlefree Connectors: SwabSleeve, REF: SCXT3-5-2000…Due to a manufacturing issue, disinfecting cap for needle-free connectors may have an incomplete seal… | ICU Medical, Inc. | 06/03/2025Open, Classified |