# K153138: Cerdak Basic

- Pathway: 510(k) (Traditional)
- Applicant: Bu Polysciences Equipment & Trading, LLC
- Decided: Jun 23, 2017 after 602 days
- Product code: FRO (Dressing, Wound, Drug)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K002550 (2000). 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)
- K071936: Woundstat, Model TC1001, Traumacure, Inc. (2007) Summary page 4.

## Indications for use
For the management of the following: Minor Cuts Minor Abrasions Minor Lacerations Minor Burns (1st degree burns)

Source page: https://510kreport.com/device/K153138
Methodology: https://510kreport.com/methodology