# K161274: Bondiloxs Topical Hemostatic Granules

- Pathway: 510(k) (Traditional)
- Applicant: Medtrade Products, Ltd.
- Decided: Jan 18, 2017 after 257 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: 4 generations back to K002550 (2000). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093593: Celox Pro, Celox Pro Otc, Celox Hemostatic Granules, Celox Pro Hemostatic Granules, Omni Stat Pro, Medtrade Products Limited (2010) Summary page 5.

## Indications for use
Bondiloxs Topical Haemostatic Granules is indicated for use as a temporary topical dressing for external bleeding control associated with minor wounds, including control of minor external bleeding and exudate from sutures and/or surgical procedures and for temporary external treatment for controlling moderate bleeding.

Source page: https://510kreport.com/device/K161274
Methodology: https://510kreport.com/methodology