Cleared Traditional

K223914 - ACTIV™ Cap (FDA 510(k) Clearance)

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

K223914 · Cleansite Medical, Inc. · General Hospital
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Apr 2024
Decision
463d
Days
Class 2
Risk

K223914 is an FDA 510(k) clearance for the ACTIV™ Cap. Classified as Cap, Device Disinfectant (product code QBP), Class II - Special Controls.

Submitted by Cleansite Medical, Inc. (Solana Beach, US). The FDA issued a Cleared decision on April 5, 2024 after a review of 463 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Cleansite Medical, Inc. devices

Submission Details

510(k) Number K223914 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 2022
Decision Date April 05, 2024
Days to Decision 463 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
335d slower than avg
Panel avg: 128d · This submission: 463d
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.