Cleared Traditional

Curos Jet Disinfecting Cap (K200299) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K200299 · 3M Company · General Hospital
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Oct 2020
Decision
266d
Days
Class 2
Risk

K200299 is an FDA 510(k) clearance for the Curos Jet Disinfecting Cap. Classified as Cap, Device Disinfectant (product code QBP), Class II - Special Controls.

Submitted by 3M Company (St. Paul, US). The FDA issued a Cleared decision on October 29, 2020 after a review of 266 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 3M Company devices

Submission Details

510(k) Number K200299 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 2020
Decision Date October 29, 2020
Days to Decision 266 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
137d slower than avg
Panel avg: 129d · This submission: 266d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 21
Devices cleared under the same product code (QBP) and FDA review panel - the closest regulatory comparables to K200299.
OTTO™ Disinfecting Cap
K252006 · Icu Medical, Inc. · Mar 2026
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
CapKlenZ
K192382 · Star Mountain Medical, Inc. · Apr 2020
SwabTip Male Disinfectant Cap
K190918 · Icu Medical · Mar 2020