# K033666: Hemaderm

- Pathway: 510(k) (Traditional)
- Applicant: Medafor, Inc.
- Decided: Dec 17, 2003 after 26 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
Longest line of descent: 3 generations back to K821150 (1982). 20 ancestors in all.
29 later devices descend from it; 4 cite it directly.
0 of 50 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021678: Hemaderm Cotaining Hemadex Clotting Beads, Medafor, Inc. (2002) Summary page 6.
- K002972: Merogel Control Gel Ent Surgical Dressing, Medtronic Xomed (2000) Summary page 7.
- K012532: Sepragel Sinus, Genzyme Corp. (2001) Summary page 7.
- K984388: HA Absorbent Wound Dressing, Convatec, A Division of E.R. Squibb & Sons (1999) Summary page 7.
- K030334: T-Scientific T-Pad, T-Scientific, Inc. (2003) Summary page 7.
- K984177: Modification to Skvekpatch, Marine Polymer Technologies, Inc. (1998) Summary page 7.
- K984069: Entaxis Nasal Packing, Les Laboratorires Brothier, S.A. (1999) Summary page 7.
- K830264: Floret Tonsil & Adenoid Sponges, Ritmed, Inc. (1983) Summary page 7.
- K000108: Rapid Rhino-Anterior 90MM, Model RR-a 90, Rapid Rhino-Posterior 100MM, Model RR-P 100, Bhk Holding (2000) Summary page 7.
- K972459: Rhinocell Nasal Packings, Boston Medical Products, Inc. (1997) Summary page 7.
- K993362: Hylasine, Biomatrix, Inc. (2000) Summary page 7.
- (no number) BioLife NoseBleed QR Powder: named in the summary without a submission number
- (no number) Single and Double Strung Tonsil Sponges and Double Strung Cylindrical Sponges: named in the summary without a submission number

## Most influential descendants
- K070211: Traumarrest and Bleedarrest Hemostatic Particles and Foam (2007), 28 descendants of its own
- K072900: Excelarrest  Foam (2007), 19 descendants of its own
- K080818: Hemcon Bandage, Hemcon Bandage Otc, Hemcon Chitoflex-Surgical Dressing (2008), 11 descendants of its own
- K102459: Nexstat (TM) Topical Hemostat Powder; Nexfoam (R) Topical Sponge (2010), 9 descendants of its own
- K120958: Posisep and Posisep X Hemostat Dressings (2012), 6 descendants of its own

## Indications for use
HemaDermTM 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 and for the temporary treatment of mild bleeding from topical ENT surgical wounds and nosebleeds. HemaDermTM 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/K033666
Methodology: https://510kreport.com/methodology