# K002488: Kelo-Cote Topical Gel

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Bio-Technologies, Inc.
- Decided: Jan 5, 2001 after 144 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
No predicates in its family tree.
4 later devices descend from it; 4 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K014036: Medtrade Products Silicone Scar Therapy Gel, Spenco Medical Corp. 2ND Skin Silicone Scar Therapy Gel, Model 09916030. (2002), 2 descendants of its own
- K083718: Beau RX Scar Care Gel (2009), 1 descendant of its own
- K131672: Microcyn Scar Management Hydrogel (2013), 0 descendants of its own
- K053481: Kelo-Cote Spray (2006), 0 descendants of its own

Source page: https://510kreport.com/device/K002488
Methodology: https://510kreport.com/methodology