# K940249: Certiburn Burn/Trauma Face Dressing /Towel Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Certified Safety Mfg., Inc.
- Decided: Oct 3, 1994 after 257 days
- Product code: LRR (First Aid Kit With Drug)
- Device class: N
- Recalls of this device: 1 (0 Class I)
- 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. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Recalls of this device
- Apr 5, 2022 · Class II · Z-1060-2022: First aid kit and cabinet components are being recalled by the supplier due to cGMP deviations at the manufacturer.

Source page: https://510kreport.com/device/K940249
Methodology: https://510kreport.com/methodology