Cleared Traditional

K170505 - SecurePortIV Catheter Securement Adhesive

K170505 is an FDA 510(k) clearance for SecurePortIV Catheter Securement Adhesive, 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 220-day FDA review.

K170505 · Adhezion Biomedical, LLC · General Hospital
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Sep 2017
Decision
220d
Days
Class 2
Risk

K170505 is an FDA 510(k) clearance for the SecurePortIV Catheter Securement Adhesive. Classified as Sealant, Microbial (product code NZP), Class II - Special Controls.

Submitted by Adhezion Biomedical, LLC (Wyoming, US). The FDA issued a Cleared decision on September 29, 2017 after a review of 220 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 - K170505

510(k) Number K170505 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 2017
Decision Date September 29, 2017
Days to Decision 220 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
91d slower than avg
Panel avg: 129d · This submission: 220d
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.