# DEN210049: Medline ART Skin Harvesting System

- Pathway: De Novo (Direct)
- Applicant: Medline Industries, Inc.
- Decided: Mar 27, 2024 after 890 days
- Product code: QYK (Semi-Automated Autologous Skin Graft Harvesting And Application Device)
- Device class: 2
- Regulation: 21 CFR 878.4795
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Indications for use
The ART (Autologous Regeneration of Tissue) Skin Harvesting System is intended for the harvesting and application of autologous, full-thickness micrografts for wounds where autologous skin grafting would be appropriate.

Source page: https://510kreport.com/device/DEN210049
Methodology: https://510kreport.com/methodology