Cleared Traditional

3M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressing (K153410) - FDA 510(k) Clearance

K153410 · 3M Company · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
May 2017
Decision
537d
Days
-
Risk

K153410 is an FDA 510(k) clearance for the 3M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressing. Classified as Securement Wound Dressing For Reduction Of Infection (product code SEL).

Submitted by 3M Company (St. Paul, US). The FDA issued a Cleared decision on May 15, 2017 after a review of 537 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General & Plastic Surgery FDA review panel. 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 & Plastic Surgery submissions.

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Submission Details

510(k) Number K153410 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 2015
Decision Date May 15, 2017
Days to Decision 537 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
422d slower than avg
Panel avg: 115d · This submission: 537d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code SEL Securement Wound Dressing For Reduction Of Infection
Device Class -
Definition These Dressings Are Intended To Be Placed Over A Vascular Or Percutaneous Device (e.g., Needle, Catheter, Drain) To Keep It Securely Anchored To The Skin, Cover And Protect The Insertion Site, And May Additionally Absorb Exudate. When Used To Secure Central Venous Or Arterial Catheters, A Securement Wound Dressing For Reduction Of Infection Is Intended To Reduce Microbial Colonization Around The Insertion Site And Reduce The Incidence Of Catheter-related Bloodstream Infections (crbsi).

Clinical Evidence

ClinicalTrials.gov
NCT01189682 Completed Interventional

Impact of Tegaderm HP and CHG in Major Catheter Related Infections and Dressing Detachment

Impact of Tegaderm HP and Tegaderm CHG in Major Catheter Related Infections and Dressing Detachment in ICU Patients a Prospective Randomized Study

1960
Patients (actual)
1
Site
Prevention
Purpose
Single blind
Masking
Condition studied Catheter-Related Infections
Study design Parallel
Eligibility All sexes · 18 Years+
Principal investigator TIMSIT Jean-François, PU/PH
Sponsor University Hospital, Grenoble
Started 2010-04-01 → Primary completion 2011-07-01
Primary outcome
Risk of major catheter infection between Group 1 and Group 2+3 assessed by an independent blind expert panel
Secondary outcome
dressing detachment : rate of unplanned dressing between Tegaderm CHG, Tegaderm HP and Tegaderm
Study completed - no results published. This trial concluded in 2011 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov