Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Newport Biosystems, 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) |
|---|---|---|---|---|---|
| K881648 | TRANSFER CONTAINER HUMIDIFIER | Newport Biosystems, Inc. | 1988-12-30 | 259 | 0 |
| K860282 | RPMI 1640 W/GLUTAMINE W/HEPES | Newport Biosystems, Inc. | 1986-02-05 | 8 | 0 |
| K855085 | TISSUE CULTURE MEDIA | Newport Biosystems, Inc. | 1986-01-13 | 24 | 0 |
| K853441 | FETAL BOVINE SERUM IN TRANSFER CONTAINER | Newport Biosystems, Inc. | 1985-08-26 | 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