Cleared Traditional

K252006 - OTTO Disinfecting Cap

K252006 is an FDA 510(k) clearance for OTTO Disinfecting Cap, manufactured by Icu Medical, Inc.. The device is a Class 2 General Hospital device with product code QBP cleared through the Traditional 510(k) pathway after a 273-day FDA review.

K252006 · Icu Medical, Inc. · General Hospital
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Mar 2026
Decision
273d
Days
Class 2
Risk

K252006 is an FDA 510(k) clearance for the OTTO™ Disinfecting Cap. Classified as Cap, Device Disinfectant (product code QBP), Class II - Special Controls.

Submitted by Icu Medical, Inc. (San Clemente, US). The FDA issued a Cleared decision on March 27, 2026 after a review of 273 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5440 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Icu Medical, Inc. devices

FDA 510(k) Submission Details - K252006

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
144d slower than avg
Panel avg: 129d · This submission: 273d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

QBP Device Classification - Class 2, Special Controls

Product Code QBP Cap, Device Disinfectant
Device Class Class 2 - 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
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - QBP Cap, Device Disinfectant

All 7
Devices cleared under the same product code (QBP) and FDA review panel - the closest regulatory comparables to K252006.
SteriHub™ Disinfecting Device and Protective Cover
K251592 · 1World Vista Medical · Feb 2026
ACTIV™ Cap
K223914 · Cleansite Medical, Inc. · Apr 2024
BD PureHub Disinfecting Cap
K193190 · Becton, Dickinson and Company · Nov 2020
Curos Jet Disinfecting Cap
K200299 · 3M Company · Oct 2020
CapKlenZ
K192382 · Star Mountain Medical, Inc. · Apr 2020
SwabTip Male Disinfectant Cap
K190918 · Icu Medical · Mar 2020