OTTO Disinfecting Cap— 510(k) K252006
Substantially EquivalentIcu Medical, Inc.
FDA 510(k) clearance K252006 for OTTO Disinfecting Cap, Substantially Equivalent on 2026-03-27. Applicant: Icu Medical, Inc.. Device class: 2.
Summary
Icu Medical's OTTO Disinfecting Cap is filed under QBP, device disinfectant caps. The record doesn't list sizes or model numbers.
Class II, 21 CFR 880.5440. General Hospital is both the classification panel and the review panel. It was a Traditional 510(k).
Icu Medical filed from San Clemente, California. The decision came 273 calendar days after receipt (June 27, 2025 to March 27, 2026).
Clearance details
- Applicant
- Icu Medical, Inc.
- Product code
- Product code QBP
- Device class
- Class 2
- Regulation
- 21 CFR 880.5440
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Clemente, CA, US
Recent devices under product code QBP
view allMore clearances from Icu Medical, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.