Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Manamed, Inc. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
175 daysmedian FDA review time
448 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K231569 | ManaFlexx 2 (model: MF002-RX, MF002-OTC) | Manamed, Inc. | 2023-11-03 | 156 | 0 |
| K222098 | ManaSport+ | Manamed, Inc. | 2023-03-08 | 233 | 0 |
| K210284 | ManaSport | Manamed, Inc. | 2022-04-26 | 448 | 0 |
| K211253 | PlasmaWave | Manamed, Inc. | 2021-05-26 | 30 | 0 |
| K200353 | ManaFlow | Manamed, Inc. | 2020-08-06 | 175 | 0 |
| K200351 | PlasmaFlight | Manamed, Inc. | 2020-08-05 | 175 | 0 |
| K160318 | PlasmaFlow | Manamed, Inc. | 2016-04-01 | 56 | 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