Medical devices, not accessories
What “accepted” means for a hemostatic dressing
A hemostatic dressing is a medical device that reaches the U.S. market only after the Food and Drug Administration has reviewed a premarket notification, known as a 510(k), and cleared it. Each of the three dressings above holds its own 510(k) clearance, listed with its entry. Two of the three also appear on the Department of Defense Committee on Tactical Combat Casualty Care (CoTCCC) recommended devices list. The program reviews every dressing against its own requirements for use by members of the public with the training the STOP THE BLEED® class provides, and accepts only those that meet them.
Only these three may be packed in a STOP THE BLEED® Intermediate or Advanced Kit. A licensee cannot substitute another dressing, and a dressing sold on its own under the STOP THE BLEED® name must be one of the three. If a kit you are offered contains something else, buy from a licensed seller and look more closely.
You need training to use a hemostatic dressing properly. They come in the Intermediate and Advanced Kits. The Basic Kit uses plain gauze instead, and packed correctly, plain gauze works. Find a class near you.
QuikClot, Combat Gauze, Celox, and NuStat are trademarks of their respective owners and are used here to identify accepted devices. FDA 510(k) clearance is a determination of substantial equivalence to a legally marketed device; it is not FDA approval or endorsement. Cleared indications vary by product and package; refer to the instructions for use supplied with the dressing. 510(k) numbers are shown for reference and should be confirmed against the FDA 510(k) database.