Curos Port Protector
FDA 510(k) K110826 · Ivera Medical
510(k) numberK110826
Submission
- Device name
- Curos Port Protector
- Applicant
- Ivera Medical
Carlsbad, CA, US - Received
- March 24, 2011
- Decision date
- June 23, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 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 |
| K142399 | DualCap IV Pole Strips(Disinfectant Caps for Male Luers)QBP · Traditional | Catheter Connections, Inc. | 11/19/2014SE |
More from Catheter Connections, Inc.
Questions and answers
When was Curos Port Protector cleared by the FDA?
Curos Port Protector (K110826) received a 510(k) decision of Substantially Equivalent on June 23, 2011, 91 days after the submission was received.
What is the product code of K110826?
The FDA product code is QBP – Cap, Device Disinfectant, a Class II (moderate risk) device regulated under 21 CFR 880.5440.