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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Icu Medical, Inc.. It received FDA 510(k) clearance on 2026-03-27 under 510(k) 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. The listed applicant is Icu Medical, Inc.. The 510(k) number is K252006.

When did OTTO™ Disinfecting Cap receive FDA 510(k) clearance?

OTTO™ Disinfecting Cap received FDA 510(k) clearance on 2026-03-27, under 510(k) number K252006.

Who is the listed applicant for OTTO™ Disinfecting Cap?

The FDA 510(k) record lists Icu Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OTTO™ Disinfecting Cap?

The FDA product code for OTTO™ Disinfecting Cap is QBP.

Other records listing Icu Medical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: QBP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251592SteriHub™ Disinfecting Device and Protective Cover1World Vista MedicalK223914ACTIV™ CapCleansite Medical, Inc.K193190BD PureHub Disinfecting CapBecton, Dickinson and CompanyK200299Curos Jet Disinfecting Cap3M CompanyK192382CapKlenZStar Mountain Medical, Inc.K190918SwabTip Male Disinfectant CapIcu Medical

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.

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