Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Beijing Konted Medical Technology Co.,Ltd · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261081 | Pocket Ultrasound System (C10MTpro,C10MXpro,C10MSpro,C10MBpr | Beijing Konted Medical Technology Co.,Ltd | 2026-07-23 | 113 | 0 |
| K241979 | Pocket Ultrasound System (C10, C10TX, C10RL, C10RLpro) | Beijing Konted Medical Technology Co.,Ltd | 2024-08-22 | 48 | 0 |
| K231354 | Pocket Ultrasound System (C10) | Beijing Konted Medical Technology Co.,Ltd | 2023-12-20 | 224 | 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