Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
F.L.W. Plastics, 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) |
|---|---|---|---|---|---|
| K900291 | MASS SPECTROMETRY MONITORING LINES AND CONNECTORS | F.L.W. Plastics, Inc. | 1990-03-28 | 65 | 0 |
| K895233 | BACTERIAL AND VIRAL FILTER | F.L.W. Plastics, Inc. | 1989-11-15 | 86 | 0 |
| K895357 | ANETHESIA BREATHING CIRCUIT | F.L.W. Plastics, Inc. | 1989-10-19 | 52 | 0 |
| K895169 | MANUAL DISPOSABLE PULMONARY RESUSCITATOR | F.L.W. Plastics, Inc. | 1989-10-13 | 64 | 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