Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medway — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
186 daysmedian FDA review time
233 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K934344 | HOME AMB-ALERT | Medway | 1994-04-29 | 233 | 0 |
| K931952 | MEDWAY OXYGEN MASK | Medway | 1993-08-20 | 122 | 0 |
| K911251 | FLEX-IV | Medway | 1991-10-28 | 221 | 0 |
| K911079 | AMB-ALERT | Medway | 1991-09-13 | 186 | 0 |
| K910880 | COMFOR-BOARD | Medway | 1991-06-06 | 97 | 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