# K123387: Quikclot Hemostatic Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Z-Medica, LLC
- Decided: Apr 12, 2013 after 161 days
- Product code: QSY (Hemostatic Wound Dressing Without Thrombin Or Other Biologics)
- Device class: U
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K002550 (2000). 15 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072474: Quikclot EX, Z-Medica Corporation (2007) Summary page 5.
- K071519: Hemcon Chitoflex-Surgical Dressing, Hemcon, Inc. (2007) Summary page 5.

## Most influential descendants
- K253017: BloodSTOP iX Trauma Matrix (TM-iX-20) (2026), 0 descendants of its own
- K251700: Ganymede 2cm diameter (FG100300); Ganymede 5cm x 5cm (FG100400); Ganymede 10cm x 10cm (FG100500); Ganymede 15cm x 15cm (FG100600); Ganymede 20cm x 30cm (FG100700); Ganymede 25cm x 25cm (FG100800); Ganymede 30cm x 30cm (FG100900); Ganymede 40cm x 40cm  (FG100999); Ganymede 7.5cm x 120cm (FG100100); Ganymede-X 2cm diameter (FG100301); Ganymede-X 5cm x 5cm (FG100401); Ganymede-X 10cm x 10cm (FG100501); Ganymede-X 15cm x 15cm (FG100601); Ganymede-X 20cm x 30cm  (FG100701); Ganymede-X 25cm (2026), 0 descendants of its own
- K151204: HEMO-Bandage (2015), 0 descendants of its own

## Recalls of this device
- Nov 17, 2017 · Class II · Z-0925-2018: A customer complained that one of the pouches in a box of 10 had "QuikClot Roll" pouch instead of "QuikClot TraumaPad" pouch. The carton as well as the remaining 9 pouches were properly identified as 
- May 17, 2017 · Class II · Z-2612-2017: Packaging breach may compromise sterility

## Indications for use
QuikClot® Hemostatic Dressing is intended for use as a topical dressing for local management of bleeding Wounds such as cuts, lacerations and abrasions. It may also be used for temporary treatment of severely bleeding wounds such as surgical wounds (operative, postoperative, dermatological, etc.) and traumatic injuries.

Source page: https://510kreport.com/device/K123387
Methodology: https://510kreport.com/methodology