Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Molecular Products , Ltd. — 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) |
|---|---|---|---|---|---|
| K240561 | Rugged Oxygen Generator (ROG) (RO01-00001) | Molecular Products , Ltd. | 2024-12-06 | 281 | 0 |
| K131016 | ROGS | Molecular Products , Ltd. | 2013-11-27 | 230 | 0 |
| K062153 | PORTABLE OXYGEN GENERATOR SYSTEM | Molecular Products , Ltd. | 2006-11-21 | 117 | 0 |
| K921803 | SOFNOLIME CARBON DIOXIDE ABSORBENT | Molecular Products , Ltd. | 1992-10-15 | 183 | 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