# Klarity Medical & Equipment (GZ) Co., Ltd.

- Location (FDA's records): Guangzhou, CN
- FDA decisions: 3 (2021–2025): 3 510(k) clearances
- Product codes: IYE (3)
- 510(k) review time since 2016: median 249 days, against 170 for FDA's reviews in the same codes and years (0 of 3 faster)
- Predicates its devices cite: 2 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- I.Z.I. Corp.: 1 (https://510kreport.com/company/izi)
- C-Rad Positioning AB: 1 (https://510kreport.com/company/c-rad-positioning)

## Recent decisions
- K241937: Klarity SGRT System (ARSG-E1A, ARSG-E3A) (Mar 18, 2025)
- K220539: Klarity SRS Baseplate, Klarity Promise Baseplate (Nov 1, 2022)
- K202747: Klarity Bolus (May 14, 2021)

Source page: https://510kreport.com/company/klarity-medical-equipment-gz