Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Leltek, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
212 daysmedian FDA review time
280 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K243226 | Ultrasound Imaging System (LU700 Series); Ultrasound Imaging | Leltek, Inc. | 2025-05-08 | 212 | 0 |
| K241161 | Ultrasound Imaging System (LK128L); Ultrasound Imaging Syste | Leltek, Inc. | 2024-09-11 | 138 | 0 |
| K222365 | Leltek Ultrasound Imaging System (Model: LU700 Series) | Leltek, Inc. | 2022-10-25 | 82 | 0 |
| K210432 | LELTEK Ultrasound Imaging System (Model: LU700 Series) | Leltek, Inc. | 2021-11-03 | 264 | 0 |
| K191235 | Leltek Ultrasound Imaging System | Leltek, Inc. | 2020-02-12 | 280 | 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