# K961227: JJ Skinner Carekits Wound Care Management/Dressing Change Tray

- Pathway: 510(k) (Traditional)
- Applicant: J.J. Skinner, Inc.
- Decided: Jun 10, 1996 after 74 days
- Product code: FRG (Wrap, Sterilization)
- Device class: 2
- Regulation: 21 CFR 880.6850
- 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. The FDA summary names no predicate by number.

## Indications for use
The JJ Skinner CareKits™ Wound Care Management/Dressing Change Tray is intended to be used by Healthcare professionals for wound care management, including, cleansing, irrigation, debridement, and dressing changes.

Source page: https://510kreport.com/device/K961227
Methodology: https://510kreport.com/methodology