# K013225: Instaclot for Otc Use, Traumasstat for Prescription Use

- Pathway: 510(k) (Traditional)
- Applicant: Medafor, Inc.
- Decided: Dec 26, 2001 after 90 days
- Product code: KMF (Bandage, Liquid)
- Device class: 1
- Regulation: 21 CFR 880.5090
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
35 later devices descend from it; 5 cite it directly.
0 of 36 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) Hemostice, 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) Dermaphylyx 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

## 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
Bleed-X™ is intended as a topical dressing for the local management of bleeding wounds such as minor cuts, lacerations and abrasions. Traumadex™ is intended as a topical dressing for the local management of bleeding wounds such as cuts, lacerations and abrasions. Under the care of a health care professional, Traumadex™ may be used for the temporary treatment of severely bleeding wounds such as surgical wounds (post-operative, donor sites, dermatological), cuts, lacerations and traumatic injuries.

Source page: https://510kreport.com/device/K013225
Methodology: https://510kreport.com/methodology