Cleared Traditional

K223669 - SecurePortIV Advanced Catheter Securement Adhesive (FDA 510(k) Clearance)

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

K223669 · Adhezion Biomedical, LLC · General Hospital
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Jun 2023
Decision
187d
Days
Class 2
Risk

K223669 is an FDA 510(k) clearance for the SecurePortIV Advanced Catheter Securement Adhesive. Classified as Sealant, Microbial (product code NZP), Class II - Special Controls.

Submitted by Adhezion Biomedical, LLC (Hudson, US). The FDA issued a Cleared decision on June 12, 2023 after a review of 187 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4370 - 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 Adhezion Biomedical, LLC devices

Submission Details

510(k) Number K223669 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 2022
Decision Date June 12, 2023
Days to Decision 187 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
59d slower than avg
Panel avg: 128d · This submission: 187d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NZP Sealant, Microbial
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4370
Definition Intended To Isolate The Site Of A Surgical Incision From Microbial Contamination And Indicated To Reduce The Risk Of Skin Flora Contamination Of The Surgical Incision Throughout A Surgical Procedure.
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.