Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Sdi Limited — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
164 daysmedian FDA review time
279 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K222583 | Stela Capsule System | Sdi Limited | 2022-10-28 | 63 | 0 |
| K222581 | Stela Automix System | Sdi Limited | 2022-10-28 | 63 | 0 |
| K214118 | Riva Cem Automix | Sdi Limited | 2022-08-30 | 243 | 0 |
| K191656 | Zipbond | Sdi Limited | 2019-12-02 | 164 | 0 |
| K172047 | Riva Star | Sdi Limited | 2018-04-11 | 279 | 0 |
| K102984 | AURA | Sdi Limited | 2010-12-08 | 62 | 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