# K041013: Suile Ointment Wound Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Hedonist Biochemical Technologies Co., Ltd.
- Decided: Jul 7, 2004 after 78 days
- Product code: FRO (Dressing, Wound, Drug)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K160872: PolyPlex Wound Dressing (2016), 4 descendants of its own
- K181315: Antimicrobial gauze sponge dressing, Antimicrobial super sponge dressing, Antimicrobial non-woven sponge dressing (2019), 1 descendant of its own
- K221755: Antimicrobial gauze sponge dressing; Antimicrobial super sponge dressing; Antimicrobial non-woven sponge dressing (2023), 0 descendants of its own
- K183681: Protego Antimicrobial Wound Dressing (2019), 0 descendants of its own
- K171191: Hexagen Derm (2017), 0 descendants of its own

## Indications for use
The SUILE Ointment Wound Dressing is indicated for the management of 1st and 2nd degree burns, partial thickness wounds, donor sites and abrasions.

Source page: https://510kreport.com/device/K041013
Methodology: https://510kreport.com/methodology