# K222143: Apis (R), Veris (TM)

- Pathway: 510(k) (Traditional)
- Applicant: Sweetbio, Inc.
- Decided: Oct 13, 2023 after 450 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: 8 generations back to K881854 (1988). 19 ancestors in all.
No later device cites it as a predicate yet.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182725: Apis, Sweetbio, Inc. (2019) Summary page 6.
- K110546: Medihoney Hydrogel Sheet Dressings with Active Leptospermum Honey, Derma Sciences, Inc. (2011) Summary page 6.

## Indications for use
Under the supervision of a healthcare professional, APIS® / VERIS™ Wound Management Devices are 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 For over-the-counter use, APIS® OTC / VERIS™ OTC Wound Management Devices may be used for: • minor abrasions • lacerations • minor cuts • minor scalds and burns

Source page: https://510kreport.com/device/K222143
Methodology: https://510kreport.com/methodology