# K133121: Chito-Sam 100,4IN X4IN,Chito-Sam, 3IN X6FT, Chito-Sam 100,3IN X10FT, Chito-Sam Active, 4INX4IN,Chito-Sam Active, 3INX6FT

- Pathway: 510(k) (Traditional)
- Applicant: Sam Medical Products
- Decided: May 22, 2014 after 234 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: 8 generations back to K002550 (2000). 24 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080097: Medtrade Products Celox Hemostatic Granules on Sheet, Medtrade Products, Ltd. (2008) Summary page 6.
- K091795: Medtrade Products Celox Trauma Gauze, Medtrade Products, Ltd. (2009) Summary page 6.
- K113560: Celox Gauze Pro, Medtrade Products, Ltd. (2012)

## Most influential descendants
- K143462: AnsCare ChitoClot Gauze (prescription use), AnsCare ChitoClot Gauze (over-the-counter use) (2015), 2 descendants of its own
- K232216: Hemoblock_S (Prescription); Hemoblock_S (OTC) (2024), 0 descendants of its own
- K222909: Axiostat Gauze (2023), 0 descendants of its own
- K172155: StatGuard Hemostatic Patch, StatGuard Hemostatic Dressing (2018), 0 descendants of its own
- K172324: Axiostat Chitosan Hemostatic Dressing (2018), 0 descendants of its own

## Indications for use
To control bleeding of lacerations, minor cuts and abrasions.

Source page: https://510kreport.com/device/K133121
Methodology: https://510kreport.com/methodology