Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Shenzhen Rainbow Technology Co., Ltd. · Predicate Candidate Screening
2 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253712 | LED Light Therapy Mask (RB-051, RB-061, RB-071, RB-052, RB-0 | Shenzhen Rainbow Technology Co., Ltd. | 2026-01-23 | 60 | 0 |
| K243423 | LED Light Therapy Mask (Model(s): RB-008, RB-030, RB-081, RB | Shenzhen Rainbow Technology Co., Ltd. | 2025-01-28 | 85 | 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