Leltek, Inc.: FDA clearances and approvals
Leltek, Inc. has 5 FDA 510(k) clearances (first 2020, latest 2025), across 1 product code in 1 review panel. Median 510(k) review time: 212 days. Since 2017 its median was 212 days, against 101 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2020 | 1 | 280 |
| 2021 | 1 | 264 |
| 2022 | 1 | 82 |
| 2023 | 0 | — |
| 2024 | 1 | 138 |
| 2025 | 1 | 212 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Leltek, Inc.'s cleared 510(k)s took a median 212 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 101 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 5 | 5 |
Review panels
- Radiology (5)
Most recent Leltek, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K243226 | Ultrasound Imaging System (LU700 Series); Ultrasound Imaging System (128 Series); Ultrasound Imaging System (LX Series) | IYN | 2025-05-08 | 212 |
| K241161 | Ultrasound Imaging System (LK128L); Ultrasound Imaging System (LK128LH); Ultrasound Imaging System (LK128C); Ultrasound Imaging System (LK128M); Ultrasound Imaging System (LK128PA); Ultrasound Imaging System (LK128E); Ultrasound Imaging System (LU700C); Ultrasound Imaging System (LU700L); Ultrasound Imaging System (LU710L); Ultrasound Imaging System (LU710LH); Ultrasound Imaging System (LU710C); Ultrasound Imaging System (LU710M); Ultrasound Imaging System (LU710PA); Ultrasound Imaging | IYN | 2024-09-11 | 138 |
| K222365 | Leltek Ultrasound Imaging System (Model: LU700 Series) | IYN | 2022-10-25 | 82 |
| K210432 | LELTEK Ultrasound Imaging System (Model: LU700 Series) | IYN | 2021-11-03 | 264 |
| K191235 | Leltek Ultrasound Imaging System | IYN | 2020-02-12 | 280 |
Recalls
openFDA lists no recalls under a recalling firm named Leltek, 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.
Frequently asked questions
How many FDA 510(k) clearances does Leltek, Inc. have?
Leltek, Inc. has 5 FDA 510(k) clearances (first 2020, latest 2025), across 1 product code in 1 review panel.
How long does FDA take to clear Leltek, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Leltek, Inc.'s cleared 510(k)s is 212 days. Since 2017: 212 days, versus 101 days for all cleared 510(k)s in the same product codes.
What devices does Leltek, Inc. make?
Its most frequent FDA product codes are IYN (System, Imaging, Pulsed Doppler, Ultrasonic, 5).
Has Leltek, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Leltek, Inc. Related entities may recall under other names.
Next steps
- See all 5 Leltek, Inc. clearances with predicates and recalls
- Run predicate analysis for product code IYN, Leltek, 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.