QuikClot Control+ Hemostatic Device

QuikClot Control+ is a sterile, non-absorbable hemostatic gauze dressing containing kaolin (a clotting agent) bound to gauze with a calcium alginate binder. It is indicated for temporary control of external bleeding and identifiable sites of internal mild, moderate, severe, and life-threatening bleeding. The device is packed into wounds with applied pressure and may remain in place up to 48 hours.

The proposed device is identical to the primary predicate (K220971) in materials of construction (gauze substrate, kaolin hemostatic agent, calcium alginate binder), available sizes, prescription-use status, patient contact time (48 hours), sterilization method (gamma), shelf-life (39 months), single-use format, peelable foil packaging, and biocompatibility per ISO 10993-1. The modification is solely to the indications for use wording, aligning terminology with the VIBe scale (mild, moderate, severe, life-threatening) to cover a broader range of identifiable internal bleeding sites.

ISO 10993-1 (biocompatibility testing for prolonged contact duration). No new testing was required since the device is identical in design and manufacture to the predicate.

Substantial equivalence is based on identity to the primary predicate in all technological and manufacturing characteristics—same materials, sizes, sterilization, shelf-life, and biocompatibility. The indications for use modification is not a design change but rather clarified wording using standardized bleeding severity terminology (VIBe scale) that encompasses the previously stated cardiac surgical and trauma-specific uses. Real-world data from 603 patient cases (404 internal, 199 external uses) demonstrated 98.7% successful bleeding control for internal use and 97% for external use across all bleeding grades and anatomical sites, providing clinical support that the device safely and effectively achieves hemostasis for the broadened indications without requiring any design or manufacturing modifications.