Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Actegy , Ltd. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
213 daysmedian FDA review time
273 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K210825 | Revitive Medic Coach (Model Number 5575AQ) | Actegy , Ltd. | 2021-12-17 | 273 | 0 |
| K192887 | Revitive Medic Plus, Revitive Advanced 2 | Actegy , Ltd. | 2020-05-04 | 207 | 0 |
| K190924 | Revitive Medic Plus, Revitive Advanced 2 | Actegy , Ltd. | 2019-07-05 | 87 | 0 |
| K152480 | Revitive Medic; Revitive MV; Revitive LV | Actegy , Ltd. | 2016-03-31 | 213 | 0 |
| K143207 | Revitive IX (OTC) | Actegy , Ltd. | 2015-03-23 | 136 | 0 |
| K140772 | AEROSURE MEDIC | Actegy , Ltd. | 2014-12-19 | 267 | 0 |
| K123354 | REVITIVE IX | Actegy , Ltd. | 2013-06-28 | 240 | 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