Cleared Traditional

K021581 - HEMOSORB (FDA 510(k) Clearance)

K021581 · On Site Gas Systems, Inc. · General & Plastic Surgery device
Download Printable Device Report (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.

View all On Site Gas Systems, Inc. devices

Submission Details

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
Regulatory Context
Review time vs. panel average
55d faster than avg
Panel avg: 114d · This submission: 59d
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
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