# K982051: Kelocate Sheeting

- Pathway: 510(k) (Traditional)
- Applicant: Allied Biomedical Corp.
- Decided: Aug 5, 1998 after 55 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.
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’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
This device may be used for the management of keloid and hypertrophic scars occurring as a result of traumatic injury or surgical procedures. This device is not intended to be used on open wounds. This device is intended for oxrerb-the-counter use.

Source page: https://510kreport.com/device/K982051
Methodology: https://510kreport.com/methodology