# K020077: Modification to Augustine Medical Wound Care System, Model 68XXX

- Pathway: 510(k) (Special)
- Applicant: Augustine Medical, Inc.
- Decided: Jan 31, 2002 after 22 days
- Product code: MSA (Dressing, Wound And Burn, Occlusive, Heated)
- Device class: 1
- Regulation: 21 CFR 878.4020
- 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 K843146 (1984). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963293: Augustine Medical Wound Care System Model 68XXX, Augustine Medical, Inc. (1997) Summary page 5.

## Indications for use
The Augustine Medical Wound Care System is intended for the local management of wounds by maintaining moisture and body temperature in the wound bed. It is indicated for partial- and full-thickness wounds, such as venous, arterial and diabetic ulcers, and Stage II through Stage IV pressure ulcers.

Source page: https://510kreport.com/device/K020077
Methodology: https://510kreport.com/methodology