# K232216: Hemoblock_S (Prescription); Hemoblock_S (OTC)

- Pathway: 510(k) (Traditional)
- Applicant: Incore Co., Ltd.
- Decided: Apr 19, 2024 after 268 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: 9 generations back to K002550 (2000). 25 ancestors in all.
No later device cites it as a predicate yet.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133121: Chito-Sam 100,4IN X4IN,Chito-Sam, 3IN X6FT, Chito-Sam 100,3IN X10FT, Chito-Sam Active, 4INX4IN,Chito-Sam Active, 3INX6FT, Sam Medical Products (2014) Summary page 5.

## Indications for use
HemoblockS (Prescription): For use as a temporary external dressing to control moderate to severe bleeding and manage external abrasions and lacerations HemoblockS (OTC): To control bleeding of minor lacerations, minor cuts and minor abrasions

Source page: https://510kreport.com/device/K232216
Methodology: https://510kreport.com/methodology