Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Klarity Medical & Equipment (GZ) Co., Ltd. · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K241937 | Klarity SGRT System (ARSG-E1A, ARSG-E3A) | Klarity Medical & Equipment (GZ) Co., Ltd. | 2025-03-18 | 259 | 0 |
| K220539 | Klarity SRS Baseplate, Klarity Promise Baseplate | Klarity Medical & Equipment (GZ) Co., Ltd. | 2022-11-01 | 249 | 0 |
| K202747 | Klarity Bolus | Klarity Medical & Equipment (GZ) Co., Ltd. | 2021-05-14 | 235 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda