# K021678: Hemaderm Cotaining Hemadex Clotting Beads

- Pathway: 510(k) (Traditional)
- Applicant: Medafor, Inc.
- Decided: Jul 12, 2002 after 52 days
- Product code: QSY (Hemostatic Wound Dressing Without Thrombin Or Other Biologics)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
46 later devices descend from it; 5 cite it directly.
0 of 47 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Calgon Vestal Labs, Kaltostat Wound Dressing: named in the summary without a submission number
- (no number) Hemostace, Sorbastace: named in the summary without a submission number
- (no number) Kendall Hydrophylic Powder Wound Dressing: named in the summary without a submission number
- (no number) Marine Polymer Technology Healtec and Syvek Patch: named in the summary without a submission number
- (no number) Dennaphylyx Calcium Alginate Wound Dressing: named in the summary without a submission number
- (no number) Closure Medical, Liquiderm Liquid Bandage: named in the summary without a submission number
- (no number) Marine Polymer Technology RDH Bandage: named in the summary without a submission number
- (no number) Vascular Solutions, Duett Flowable Hemostat: named in the summary without a submission number
- (no number) Hospal Tipstop Compression Dressing: named in the summary without a submission number

## Most influential descendants
- K033666: Hemaderm (2003), 29 descendants of its own
- K070211: Traumarrest and Bleedarrest Hemostatic Particles and Foam (2007), 28 descendants of its own
- K072900: Excelarrest  Foam (2007), 19 descendants of its own
- K080210: Pro QR Advanced Formula Powder (2009), 16 descendants of its own
- K093593: Celox Pro, Celox Pro Otc, Celox Hemostatic Granules, Celox Pro Hemostatic Granules, Omni Stat Pro (2010), 13 descendants of its own

## Indications for use
HemaDerm™ is intended for use under the care of a health care professional as a topical dressing for the temporary treatment of severely bleeding wounds such as surgical wounds (post-operative, donor sites, dermatological), minor cuts and lacerations. HemaDerm™ is intended for use under the care of a health care professional for the local management and control of bleeding from percutaneous needle access, vascular access sites and percutaneous catheters.

Source page: https://510kreport.com/device/K021678
Methodology: https://510kreport.com/methodology