Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Sun-Rain System Corp. — 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) |
|---|---|---|---|---|---|
| K090542 | SUN-RAIN ULTRASONIC THERAPY MODELS, SU-300, SU-400, SU-500, | Sun-Rain System Corp. | 2009-10-23 | 235 | 0 |
| K024013 | SUN-RAIN ULTRASONIC THERAPY, SU-100 | Sun-Rain System Corp. | 2003-10-31 | 331 | 0 |
| K011913 | SUN-TENS PALM TYPE R5/COMPACT WIRELES M2 EMS SERIES | Sun-Rain System Corp. | 2001-10-26 | 129 | 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