Cleared Traditional

K021581 - HEMOSORB

K021581 · On Site Gas Systems, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2002
Decision
59d
Days
-
Risk

K021581 is an FDA 510(k) clearance for the HEMOSORB. Classified as Hemostatic Wound Dressing Without Thrombin Or Other Biologics (product code QSY).

Submitted by On Site Gas Systems, Inc. (Newington, US). The FDA issued a Cleared decision on July 12, 2002 after a review of 59 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 - K021581

510(k) Number K021581 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 2002
Decision Date July 12, 2002
Days to Decision 59 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
56d faster than avg
Panel avg: 115d · This submission: 59d
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 124
Devices cleared under the same product code (QSY) and FDA review panel - the closest regulatory comparables to K021581.
T-SCIENTIFIC T-PAD
K030334 · T-Scientific, Inc. · Apr 2003
HEMCON BANDAGE
K023298 · Hemcon, Inc. · Nov 2002
CHITO-SEAL
K021062 · Abbott Vascular, Inc. · Aug 2002
HEMADERM COTAINING HEMADEX CLOTTING BEADS
K021678 · Medafor, Inc. · Jul 2002
QUICKCLOT
K013390 · On Site Gas Systems, Inc. · May 2002
SEAL-ON TOPICAL HEMPSTATIC POWDER SPRAY
K010933 · Alltracel Pharma , Ltd. · Jan 2002