Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Healcerion Co., Ltd. — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K211665 | SONON Ultrasound Imaging System, Model: SONON300C | Healcerion Co., Ltd. | 2022-05-16 | 349 | 0 |
| K212400 | SONON Ultrasound Imaging System, Model: SONON 500L | Healcerion Co., Ltd. | 2022-04-22 | 263 | 0 |
| K170085 | SONON Ultrasound Imaging System, Model: 300L | Healcerion Co., Ltd. | 2017-10-12 | 275 | 0 |
| K151339 | SONON Ultrasound Imaging System (Model: SONON 300C) | Healcerion Co., Ltd. | 2015-09-10 | 114 | 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