Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Shaw Sun Systems — 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) |
|---|---|---|---|---|---|
| K885184 | SHAW SUN SYSTEMS MODEL 2400 | Shaw Sun Systems | 1989-01-09 | 27 | 0 |
| K882331 | SHAW SUN SYSTEMS MODEL 1600 | Shaw Sun Systems | 1988-06-22 | 16 | 0 |
| K854515 | SHAW SUN SYSTEMS 1000, 2000 & 3200 | Shaw Sun Systems | 1985-11-25 | 13 | 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