Cleared Traditional

K030334 - T-SCIENTIFIC T-PAD

K030334 · T-Scientific, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2003
Decision
80d
Days
-
Risk

K030334 is an FDA 510(k) clearance for the T-SCIENTIFIC T-PAD. Classified as Hemostatic Wound Dressing Without Thrombin Or Other Biologics (product code QSY).

Submitted by T-Scientific, Inc. (Houston, US). The FDA issued a Cleared decision on April 21, 2003 after a review of 80 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K030334

510(k) Number K030334 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 2003
Decision Date April 21, 2003
Days to Decision 80 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
35d faster than avg
Panel avg: 115d · This submission: 80d
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.

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 K030334.
CLO-SURPLUSP.A.D.
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HEMADERM
K033666 · Medafor, Inc. · Dec 2003
HEMCON BANDAGE OTC
K030946 · Hemcon, Inc. · Jun 2003
HEMCON BANDAGE
K023298 · Hemcon, Inc. · Nov 2002
CHITO-SEAL
K021062 · Abbott Vascular, Inc. · Aug 2002
HEMOSORB
K021581 · On Site Gas Systems, Inc. · Jul 2002
K030334 · T-SCIENTIFIC T-PAD
Download PDF FDA Summary T-Scientific, Inc.