# K242383: Apex Locator

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Rogin Medical Co., Ltd.
- Decided: Mar 7, 2025 after 207 days
- Product code: LQY (Locator, Root Apex)
- 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: 6 generations back to K992233 (1999). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212178: Root Apex Locator, Foshan Coxo Medical Instrument Co., Ltd. (2022) Summary page 5.

## Indications for use
Apex Locator is used to detect the apex of root canal. This device must only be used in hospital environments, clinics or dental offices by qualified dental personnel.

Source page: https://510kreport.com/device/K242383
Methodology: https://510kreport.com/methodology