Cleared Traditional

K223669 - SecurePortIV Advanced Catheter Secureme...

K223669 is an FDA 510(k) clearance for SecurePortIV Advanced Catheter Secureme..., manufactured by Adhezion Biomedical, LLC. The device is a Class 2 General Hospital device with product code NZP cleared through the Traditional 510(k) pathway after a 187-day FDA review.

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

FDA 510(k) Submission Details - K223669

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
58d slower than avg
Panel avg: 129d · This submission: 187d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NZP Device Classification - Class 2, Special Controls

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.