# K220539: Klarity SRS Baseplate, Klarity Promise Baseplate

- Pathway: 510(k) (Traditional)
- Applicant: Klarity Medical & Equipment (GZ) Co., Ltd.
- Decided: Nov 1, 2022 after 249 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- 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
1. Klarity SRS Baseplate: The device is indicated to position and/or immobilize adult and pediatric patients undergoing photon and electron radiation therapy of the head, brain, and neck. The device provides noninvasive immobilization by supporting the patient and enabling attachment of a patient specific thermoplastic mask that conforms to the patient's features to provide accurate, reproducible positioning. repositioning and immobilization. The Klarity SRS Basplate allows the patient to undergo diagnostic imaging in the same position as that of the treatment position enabling more accurate radiation therapy. 2. Klarity Promise Baseplate The device is indicated to position and/or immobilize adult and pediatric patients undergoing proton radiation therapy of the head, brain, and neck. The device provides noninvasive immobilization by supporting the patient and enabling attachment of a patient specific thermoplastic mask that conforms to the patient's features to provide accurate, reproducible positioning. repositioning and immobilization. The Klarity Promise Baseplate allows the patient to undergo diagnostic imaging in the same position as that of the treatment position enabling more accurate radiation therapy.

Source page: https://510kreport.com/device/K220539
Methodology: https://510kreport.com/methodology