# K963293: Augustine Medical Wound Care System Model 68XXX

- Pathway: 510(k) (Traditional)
- Applicant: Augustine Medical, Inc.
- Decided: Mar 28, 1997 after 219 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: 1 generation back to K843146 (1984). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K914207: Clearsite (R) Sterile Wound Care Dressing, Ndm Acquisition Corp. (1991) Summary page 20.
- K920677: Clearsite Hydrogel Wound Dressing Modification, New Dimensions IN Medicine, Inc. (1992) Summary page 20.
- K860085: Lyofoam Wound Dressings, Acme United Corp. (1986) Summary page 20.
- K843146: Micro-Temp Pumps & Micro-Temp Pads, Seabrook Medical Systems, Inc. (1984) Summary page 20.

## Most influential descendants
- K020077: Modification to Augustine Medical Wound Care System, Model 68XXX (2002), 0 descendants of its own

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

Source page: https://510kreport.com/device/K963293
Methodology: https://510kreport.com/methodology