Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Sooil Development 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) |
|---|---|---|---|---|---|
| K071418 | DANA 3CC SYRINGE INSULIN RESERVOIR | Sooil Development Co., Ltd. | 2007-09-04 | 105 | 0 |
| K063126 | DANA DIABECARE IIS | Sooil Development Co., Ltd. | 2007-02-02 | 112 | 0 |
| K022317 | DANA DIABECARE II INSULIN PUMP & SUPERLINE-EASYRELEASE, SOFT | Sooil Development Co., Ltd. | 2002-08-02 | 16 | 0 |
| K001604 | DANA DIABECARE | Sooil Development Co., Ltd. | 2000-08-14 | 82 | 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