Levita Magnetics International Corp: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Levita Magnetics International Corp” (first 2017, latest 2025), plus 1 De Novo decision, across 1 product code in 1 review panel. Median 510(k) review time under this name: 117 days. Since 2017 the median was 117 days, against 117 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2017 | 1 | 22 |
| 2018 | 1 | 167 |
| 2019 | 1 | 117 |
| 2020 | 1 | 275 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 1 | 240 |
| 2024 | 0 | — |
| 2025 | 2 | 72 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Levita Magnetics International Corp took a median 117 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 117 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| PNL | Magnetic Surgical System | 8 | 7 |
Review panels
Most recent Levita Magnetics International Corp 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K252435 | Magnetic Surgical System | PNL | 2025-09-26 | 56 |
| K250746 | Magnetic Surgical System | PNL | 2025-06-07 | 87 |
| K223673 | Surgeon Controlled Arm | PNL | 2023-08-04 | 240 |
| K191762 | Magnetic Surgical System | PNL | 2020-04-01 | 275 |
| K190006 | Magnetic Surgical System | PNL | 2019-04-29 | 117 |
| K180894 | Magnetic Surgical System | PNL | 2018-09-19 | 167 |
| K171429 | Magnetic Surgical System | PNL | 2017-06-06 | 22 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN150007 | De Novo | Magnetic Surgical System | 2016-06-13 |
Recalls
openFDA lists no recalls under a recalling firm named Levita Magnetics International Corp.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Levita Magnetics International Corp?
FDA lists 7 510(k) clearances under the applicant name “Levita Magnetics International Corp” (first 2017, latest 2025), plus 1 De Novo decision, across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Levita Magnetics International Corp?
The median time from FDA receipt to decision across 510(k)s cleared under the name Levita Magnetics International Corp is 117 days. Since 2017: 117 days, versus 117 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Levita Magnetics International Corp?
The most frequent FDA product codes under this applicant name are PNL (Magnetic Surgical System, 8).
Next steps
- See all 7 Levita Magnetics International Corp clearances with predicates and recalls
- Run predicate analysis for product code PNL, Levita Magnetics International Corp's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.