Cleared Traditional

K091194 - ALGISEAL PAD

K091194 · Evolution Medical Technologies, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2009
Decision
25d
Days
-
Risk

K091194 is an FDA 510(k) clearance for the ALGISEAL PAD. Classified as Hemostatic Wound Dressing Without Thrombin Or Other Biologics (product code QSY).

Submitted by Evolution Medical Technologies, LLC (Portland, US). The FDA issued a Cleared decision on May 18, 2009 after a review of 25 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 - K091194

510(k) Number K091194 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 2009
Decision Date May 18, 2009
Days to Decision 25 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
90d faster than avg
Panel avg: 115d · This submission: 25d
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 K091194.
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CHITOGAUZE,2 IN X 2 IN,8 PLY, 4 IN X 4 IN 8 PLY, 4 IN X 8 IN, 8PLY, 1 IN X 4 IN, 8PLY, CHITOGAUZE, PACKAGING STRIP, 1/2
K092357 · Hem Con Medical Technologies, Inc. · Aug 2009
QUIKCLOT INTEVENTIONAL, MODEL P/N 182
K090620 · Z-Medica Corporation · Apr 2009
CHITOGAUZE, MODELS 130, 131, 263, 264, 265, 266
K090026 · Hem Con Medical Technologies, Inc. · Mar 2009
SOFTSEAL-STF
K090100 · Chitogen, Inc. · Mar 2009
K091194 · ALGISEAL PAD
Download PDF FDA Summary Evolution Medical Tec…