# K193189: RFID Localization System

- Pathway: 510(k) (Traditional)
- Applicant: Health Beacons, Inc.
- Decided: May 6, 2020 after 169 days
- Product code: NEU (Marker, Radiographic, Implantable)
- Device class: 2
- Regulation: 21 CFR 878.4300
- 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 K171767 (2017). 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)
- K190932: RFID Localization System, Health Beacons, Inc. (2019) Summary page 5.

## Indications for use
The Tag of the RFLS is intended for percutaneous placement in the breast to mark (>30 days) a lesion intended for surgical removal. Using image guidance (such as ultrasound or radiography) or aided by non-imaging guidance (RFLS), the RFID Tag is located and surgically removed with the target tissue. The RFLS is intended only for the non-imaging detection and localization of the Tag that has been implanted in a lesion intended for surgical removal.

Source page: https://510kreport.com/device/K193189
Methodology: https://510kreport.com/methodology