Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Sialo Technology, 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) |
|---|---|---|---|---|---|
| K093785 | MODULAR ENDOSCOPE | Sialo Technology, Ltd. | 2010-08-18 | 252 | 0 |
| K082735 | STONE GRASPING BASKET, MODEL PD-T1 2115 | Sialo Technology, Ltd. | 2009-03-13 | 176 | 0 |
| K072334 | SIALO DRAIN | Sialo Technology, Ltd. | 2008-07-18 | 333 | 0 |
| K072749 | SIALO BALLOON DILATATION CATHETER | Sialo Technology, Ltd. | 2008-05-14 | 230 | 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