OTTO Disinfecting Cap— 510(k) K252006

Substantially Equivalent

Icu Medical, Inc.

FDA 510(k) clearance K252006 for OTTO Disinfecting Cap, Substantially Equivalent on 2026-03-27. Applicant: Icu Medical, Inc.. Device class: 2.

Clearance details

Applicant: Icu Medical, Inc.
Product code: Code QBP
Device class: Class 2
Regulation: 21 CFR 880.5440
Advisory panel: General Hospital
Date received: 2025-06-27
Decision date: 2026-03-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Clemente, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code QBP

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More clearances from Icu Medical, Inc.

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K242115 — Plum Duo Precision IV Pump2025-04-02

Data sourced from openFDA. This site is unofficial and independent of the FDA.