# K053481: Kelo-Cote Spray

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Bio-Technologies, Inc.
- Decided: Apr 14, 2006 after 121 days
- Product code: MDA (Elastomer, Silicone, For Scar Management)
- Device class: 1
- Regulation: 21 CFR 878.4025
- 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 K002338 (2001). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002488: Kelo-Cote Topical Gel, Advanced Bio-Technologies, Inc. (2001) Summary page 1.
- K022645: CURAD, Beiersdorf AG (2002) Summary page 1.

## Indications for use
Kelo-Cote Spray is a topical silicone spray intended for the management of old and new hypertrophic and keloid scarring on scars resulting from bums, general surgical procedures and trauma wounds.

Source page: https://510kreport.com/device/K053481
Methodology: https://510kreport.com/methodology