Cleared Traditional

K150916 - HemCon Bandage PRO, HemCon Patch PRO, HemCon Strip PRO, HemCon Strip First Aid PRO, ChitoFlex PRO

K150916 · Hem Con Medical Technologies, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2015
Decision
218d
Days
-
Risk

K150916 is an FDA 510(k) clearance for the HemCon Bandage PRO, HemCon Patch PRO, HemCon Strip PRO, HemCon Strip First Ai.... Classified as Hemostatic Wound Dressing Without Thrombin Or Other Biologics (product code QSY).

Submitted by Hem Con Medical Technologies, Inc. (Portland, US). The FDA issued a Cleared decision on November 10, 2015 after a review of 218 days - an extended review cycle.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K150916

510(k) Number K150916 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 2015
Decision Date November 10, 2015
Days to Decision 218 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
103d slower than avg
Panel avg: 115d · This submission: 218d
Pathway characteristics
Predicate-based equivalence.

QSY Device Classification - Class 0,

Product Code QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics
Device Class -
Definition To Temporarily Control Bleeding And Cover External Wounds.

Clinical Evidence

ClinicalTrials.gov
NCT00716365 Completed Interventional

USF Hemostasis: USage of HemCon for Femoral Hemostasis After Percutaneous Procedures

USF Hemostasis: USage of HemCon for Femoral Hemostasis After Percutaneous

278
Patients (actual)
1
Site
Supportive_care
Purpose
Open label
Masking
Condition studied Coronary Angiography
Study design Parallel
Eligibility All sexes · 18 Years+
Principal investigator Morris Mosseri, MD
Sponsor Meir Medical Center
Started 2008-01-01 → Primary completion 2009-01-01 → Completed 2011-08-01
Primary outcome
Primary efficacy endpoint will be time to hemostasis.
Secondary outcome
be safety (complication rate) and satisfaction of patients regarding time to sitting incline and time to ambulation. 25% of patients from each arm will be randomized for Duplex examination of the femoral artery at the access site.
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

Regulatory Peers - QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics

All 124
Devices cleared under the same product code (QSY) and FDA review panel - the closest regulatory comparables to K150916.
BloodSTOP iX Battle Matrix
K160130 · Lifescience Plus, Inc. · Jun 2016
Nustat XR
K160578 · Beeken Biomedical, LLC · Jun 2016
Prometheus ChitoGauze XR PRO
K153582 · Hem Con Medical Technologies, Inc. · May 2016
AnsCare ChitoClot Pad
K150963 · Benq Materials Corporation · Nov 2015
HEMO-Bandage
K151204 · Coreleader Biotech Co., Ltd. · Jul 2015
Hemogrip Patch
K143466 · Remedium Technologies, Inc. · Jun 2015