OTTO Disinfecting Cap
FDA 510(k) K252006 · Icu Medical, Inc.
510(k) numberK252006
Submission
- Device name
- OTTO Disinfecting Cap
- Applicant
- Icu Medical, Inc.
San Clemente, CA, US - Received
- June 27, 2025
- Decision date
- March 27, 2026
- 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 |
|---|---|---|---|
| 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 |
More from Excelsior Medical Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K252130 | LifeShield Infusion Safety Software SuitePHC · Traditional | 04/02/2026SE |
| K251980 | ClaveQS BagKPE · Traditional | 03/20/2026SE |
| K250616 | Clave Neutral-Displacement Needlefree ConnectorsFPA · Traditional | 06/05/2025SE |
| K242117 | LifeShield Infusion Safety Software SuitePHC · Traditional | 04/02/2025SE |
| K242115 | Plum Duo Precision IV PumpFRN · Traditional | 04/02/2025SE |
| K242114 | Plum Solo Precision IV PumpFRN · Traditional | 04/02/2025SE |
| K243985 | Rio Drug Reconstitution Transfer DeviceLHI · Traditional | 01/22/2025SE |
| K232048 | Cogent Hemodynamic Monitoring System; Cogent HMSDXG · Traditional | 12/20/2023SE |
| K223607 | Plum Duo Infusion SystemFRN · Traditional | 08/24/2023SE |
| K223606 | LifeShield Infusion Safety Software SuitePHC · Traditional | 08/24/2023SE |
Questions and answers
When was OTTO Disinfecting Cap cleared by the FDA?
OTTO Disinfecting Cap (K252006) received a 510(k) decision of Substantially Equivalent on March 27, 2026, 273 days after the submission was received.
What is the product code of K252006?
The FDA product code is QBP – Cap, Device Disinfectant, a Class II (moderate risk) device regulated under 21 CFR 880.5440.