Cleared Traditional

K103245 - CELSTAT (FDA 510(k) Clearance)

K103245 · Baxter Healthcare Corp · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2011
Decision
141d
Days
-
Risk

K103245 is an FDA 510(k) clearance for the CELSTAT. Classified as Hemostatic Wound Dressing Without Thrombin Or Other Biologics (product code QSY).

Submitted by Baxter Healthcare Corp (Mcgaw Park, US). The FDA issued a Cleared decision on March 23, 2011 after a review of 141 days - within the typical 510(k) review window.

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 Baxter Healthcare Corp devices

Submission Details

510(k) Number K103245 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 2010
Decision Date March 23, 2011
Days to Decision 141 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
27d slower than avg
Panel avg: 114d · This submission: 141d
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 126
Devices cleared under the same product code (QSY) and FDA review panel - the closest regulatory comparables to K103245.
BloodSTOP iX Trauma Matrix (TM-iX-20)
K253017 · Lifescience Plus, Inc. · Apr 2026
Ganymede 2cm diameter (FG100300)
K251700 · Speciality Fibres and Materials Limited · Feb 2026
MFUSE (MS001)
K250319 · Machina Medical, Inc. · Dec 2025
TRAUMAGEL® 2.0 Hemostatic Gel
K253609 · Cresilon, Inc. · Dec 2025
TRAUMAGEL®
K240713 · Cresilon, Inc. · Aug 2024
Polysaccharide Hemostatic Powder (HP-2, HP-3, HP-5)
K240097 · Ushare Medical, Inc. · May 2024