DualCap IV Pole Strips(Disinfectant Caps for Male Luers)
FDA 510(k) K142399 · Catheter Connections, Inc.
510(k) numberK142399
Submission
- Device name
- DualCap IV Pole Strips(Disinfectant Caps for Male Luers)
- Applicant
- Catheter Connections, Inc.
Salt Lake City, UT, US - Received
- August 27, 2014
- Decision date
- November 19, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QBP – Cap, Device Disinfectant
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5440
- Specialty
- General Hospital
Disinfect needleless access valves and may act as a physical barrier to contamination if not removed for a set period of time
Other 510(k)s with product code QBP
| 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 |
| K130975 | Swabcap and SwabflushQBP · Traditional | Excelsior Medical Corp. | 12/24/2013SE |
More from Excelsior Medical Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K142806 | DualCapQBP · Traditional | 05/22/2015SE |
| K123967 | Catheter Connections' Dark Blue Dualcap for Male LuersQBP · Special | 01/22/2013SE |
| K123065 | Catheter Connections Dualcap SoloQBP · Special | 12/14/2012SE |
| K113842 | Catheter Connections' Dualcap SoloQBP · Special | 01/27/2012SE |
| K112985 | Catheter Connections' Dualcap DuoQBP · Special | 11/09/2011SE |
| K093229 | Catheter Connections DualcapQBP · Traditional | 04/08/2010SE |
Questions and answers
When was DualCap IV Pole Strips(Disinfectant Caps for Male Luers) cleared by the FDA?
DualCap IV Pole Strips(Disinfectant Caps for Male Luers) (K142399) received a 510(k) decision of Substantially Equivalent on November 19, 2014, 84 days after the submission was received.
What is the product code of K142399?
The FDA product code is QBP – Cap, Device Disinfectant, a Class II (moderate risk) device regulated under 21 CFR 880.5440.