K252006 is an FDA 510(k) clearance for the OTTO™ Disinfecting Cap. This device is classified as a Cap, Device Disinfectant (Class II - Special Controls, product code QBP).
Submitted by Icu Medical, Inc. (San Clemente, US). The FDA issued a Cleared decision on March 27, 2026, 273 days after receiving the submission on June 27, 2025.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440. Disinfect Needleless Access Valves And May Act As A Physical Barrier To Contamination If Not Removed For A Set Period Of Time.
| 510(k) Number | K252006 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 27, 2025 |
| Decision Date | March 27, 2026 |
| Days to Decision | 273 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | QBP - Cap, Device Disinfectant |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5440 |
| Definition | Disinfect Needleless Access Valves And May Act As A Physical Barrier To Contamination If Not Removed For A Set Period Of Time |