Cleared Traditional

Zeolite Hemostatic Cotton (K223495) - FDA 510(k) Clearance

K223495 · Hangzhou Zeo-Innov Life Technology Co., Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2023
Decision
162d
Days
-
Risk

K223495 is an FDA 510(k) clearance for the Zeolite Hemostatic Cotton. Classified as Hemostatic Wound Dressing Without Thrombin Or Other Biologics (product code QSY).

Submitted by Hangzhou Zeo-Innov Life Technology Co., Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on May 2, 2023 after a review of 162 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 Hangzhou Zeo-Innov Life Technology Co., Ltd. devices

Submission Details

510(k) Number K223495 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 2022
Decision Date May 02, 2023
Days to Decision 162 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
47d slower than avg
Panel avg: 115d · This submission: 162d
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 K223495.
Celox Rapid X-Ray Gauze
K230589 · Medtrade Products , Ltd. · Nov 2023
Hemostatic Dressing
K213413 · Jiangsu Newvalue Medical Products Co., Ltd. · Sep 2023
Cresilon Hemostatic Gel, CHG, Cresilon Hemostatic Gel (CHG)
K213652 · Cresilon, Inc. · Jun 2023
Axiostat Gauze
K222909 · Advamedica, Inc. · Apr 2023
S.E.A.L. Hemostatic Wound Spray
K210751 · Bc3 Technologies, Inc. · Feb 2023
Vascette HP (hemostatic pad)
K220566 · Koag, LLC · Jul 2022