# 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

- Pathway: 510(k) (Traditional)
- Applicant: Speciality Fibres and Materials Limited
- Decided: Feb 26, 2026 after 269 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: 7 generations back to K002550 (2000). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123387: Quikclot Hemostatic Dressing, Z-Medica, LLC (2013) Summary page 6.

## Indications for use
Over the counter: Ganymede and Ganymede-X are intended for temporary external use to stop bleeding of superficial wounds, minor cuts, and abrasions. Prescription Use: Ganymede and Ganymede-X are intended to be used as a hemostatic dressing for local temporary management of moderately to severely bleeding wounds such as surgical wounds (operative, postoperative, dermatological), including junctional wounds not amenable to tourniquet use and traumatic injuries

Source page: https://510kreport.com/device/K251700
Methodology: https://510kreport.com/methodology