Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Porta Ray, Inc. — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K864339 | PORTA RAY MODEL 325 | Porta Ray, Inc. | 1986-12-15 | 41 | 0 |
| K811082 | BETA I & BETA II | Porta Ray, Inc. | 1981-05-21 | 30 | 0 |
| K810276 | ALPHA I AND ALPHA II | Porta Ray, Inc. | 1981-03-11 | 37 | 0 |
| K792665 | PIXIE | Porta Ray, Inc. | 1980-01-29 | 33 | 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