# K181478: Roosin Xeroform Petrolatum Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Roosin Medical Co., Ltd.
- Decided: Sep 13, 2019 after 465 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
Longest line of descent: 2 generations back to K973507 (1997). 2 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152970: Dynarex Xeroform Petrolatum Dressing, Dynarex Corporation (2016) Summary page 4.

## Most influential descendants
- K193439: MEBO Wound Dressing (2020), 1 descendant of its own
- K222657: MEBO Wound Dressing (2022), 0 descendants of its own

## Indications for use
Roosin Xeroform Petrolatum Dressing is intended for use as a primary contact layer in dressing wounds such as lacerations, skin graft recipient sites, newly sutured wounds, abrasions, and minor or partial thickness burns. It may also be used as an initial layer in dressing surgical wounds with light exudate.

Source page: https://510kreport.com/device/K181478
Methodology: https://510kreport.com/methodology