OTTO Disinfecting Cap
K-Number: K252006 · 2026-03-27
ApplicantIcu Medical, Inc.
Decision Date2026-03-27
Product CodeQBP
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
OTTO Disinfecting Cap is a medical device manufactured by Icu Medical, Inc.. It received FDA 510(k) clearance on 2026-03-27 under approval number K252006. The device is classified under product code QBP. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the OTTO Disinfecting Cap?
OTTO Disinfecting Cap is a medical device that received FDA 510(k) clearance on 2026-03-27. It is manufactured by Icu Medical, Inc.. The 510(k) number is K252006.
When was OTTO Disinfecting Cap approved by the FDA?
OTTO Disinfecting Cap received FDA 510(k) clearance on 2026-03-27, under approval number K252006.
What company makes OTTO Disinfecting Cap?
OTTO Disinfecting Cap is manufactured by Icu Medical, Inc..
What is the FDA product code for OTTO Disinfecting Cap?
The FDA product code for OTTO Disinfecting Cap is QBP.
Other Devices by Icu Medical, Inc.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.