# K182725: Apis

- Pathway: 510(k) (Traditional)
- Applicant: Sweetbio, Inc.
- Decided: May 31, 2019 after 245 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: 7 generations back to K881854 (1988). 16 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083334: Elasto-Gel Manuka Honey Wound Dressing, Southwest Technologies, Inc. (2009) Summary page 4.
- K112580: Collagen Wound Dressing, Dalim Tissen Co., Ltd. (2012) Summary page 4.

## Most influential descendants
- K222143: Apis (R), Veris (TM) (2023), 0 descendants of its own
- K211972: Omeza Collagen Matrix (2021), 0 descendants of its own

## Indications for use
Apis is indicated for use in management of wounds, including • full and partial thickness wounds • pressure ulcers (stages I-IV) • venous stasis ulcers • diabetic ulcers • abrasion • surface wounds • traumatic wounds (healing by secondary intention) • donor site wounds • surgical wounds

Source page: https://510kreport.com/device/K182725
Methodology: https://510kreport.com/methodology