Pelvital USA, Inc.: FDA clearances and approvals
Pelvital USA, Inc. has 5 FDA 510(k) clearances (first 2020, latest 2024), across 1 product code in 1 review panel. Median 510(k) review time: 88 days. Since 2017 its median was 88 days, against 136 days for all cleared 510(k)s in the same product codes. It is the industry lead sponsor of 1 device clinical trial on ClinicalTrials.gov.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2020 | 1 | 142 |
| 2021 | 2 | 29 |
| 2022 | 0 | — |
| 2023 | 1 | 88 |
| 2024 | 1 | 129 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Pelvital USA, Inc.'s cleared 510(k)s took a median 88 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 136 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HIR | Perineometer | 5 | 5 |
Review panels
Most recent Pelvital USA, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K240805 | Flyte Mechanotherapy System, MTI-1.5 (MTI-1.5) | HIR | 2024-08-01 | 129 |
| K233362 | Flyte Mechanotherapy System (aka Flyte System) (MTI-1.0) | HIR | 2023-12-29 | 88 |
| K212655 | Flyte | HIR | 2021-09-21 | 29 |
| K210764 | Flyte | HIR | 2021-04-13 | 29 |
| K200409 | Pelvital System | HIR | 2020-07-10 | 142 |
Recalls
openFDA lists no recalls under a recalling firm named Pelvital USA, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Device clinical trials
Pelvital USA, Inc. is the industry lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT02954042: Pelvital Stress Urinary Incontinence Training Device: P-SUIT (Completed, started 2017-03-10)
Frequently asked questions
How many FDA 510(k) clearances does Pelvital USA, Inc. have?
Pelvital USA, Inc. has 5 FDA 510(k) clearances (first 2020, latest 2024), across 1 product code in 1 review panel.
How long does FDA take to clear Pelvital USA, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Pelvital USA, Inc.'s cleared 510(k)s is 88 days. Since 2017: 88 days, versus 136 days for all cleared 510(k)s in the same product codes.
What devices does Pelvital USA, Inc. make?
Its most frequent FDA product codes are HIR (Perineometer, 5).
Has Pelvital USA, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Pelvital USA, Inc. Related entities may recall under other names.
Next steps
- See all 5 Pelvital USA, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HIR, Pelvital USA, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.