Cleared Traditional

Vascette HP (hemostatic pad) (K220566) - FDA 510(k) Clearance

K220566 · Koag, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2022
Decision
151d
Days
-
Risk

K220566 is an FDA 510(k) clearance for the Vascette HP (hemostatic pad). Classified as Hemostatic Wound Dressing Without Thrombin Or Other Biologics (product code QSY).

Submitted by Koag, LLC (Vonore, US). The FDA issued a Cleared decision on July 29, 2022 after a review of 151 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.

View all Koag, LLC devices

Submission Details

510(k) Number K220566 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 2022
Decision Date July 29, 2022
Days to Decision 151 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
36d slower than avg
Panel avg: 115d · This submission: 151d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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

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

All 28
Devices cleared under the same product code (QSY) and FDA review panel - the closest regulatory comparables to K220566.
Zeolite Hemostatic Cotton
K223495 · Hangzhou Zeo-Innov Life Technology Co., Ltd. · May 2023
Axiostat Gauze
K222909 · Advamedica, Inc. · Apr 2023
S.E.A.L. Hemostatic Wound Spray
K210751 · Bc3 Technologies, Inc. · Feb 2023
Zeolite Hemostatic Gauze
K211570 · Hangzhou Zeo-Innov Life Technology Co., Ltd. · Feb 2022
Axiostat Patch
K202830 · Advamedica, Inc. · Apr 2021
Hemostatic Xerogel Sponge
K192671 · Solaplus Biotech Co., Ltd. · Aug 2020