Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Pelvital USA, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
88 daysmedian FDA review time
142 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K240805 | Flyte Mechanotherapy System, MTI-1.5 (MTI-1.5) | Pelvital USA, Inc. | 2024-08-01 | 129 | 0 |
| K233362 | Flyte Mechanotherapy System (aka Flyte System) (MTI-1.0) | Pelvital USA, Inc. | 2023-12-29 | 88 | 0 |
| K212655 | Flyte | Pelvital USA, Inc. | 2021-09-21 | 29 | 0 |
| K210764 | Flyte | Pelvital USA, Inc. | 2021-04-13 | 29 | 0 |
| K200409 | Pelvital System | Pelvital USA, Inc. | 2020-07-10 | 142 | 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