Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Sb Lucius, Inc. — Predicate Candidate Screening
15 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
81 daysmedian FDA review time
84 days90th percentile
15clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K031010 | MIRACLE 98 | Sb Lucius, Inc. | 2003-06-25 | 86 | 0 |
| K024136 | AIGIS-SOFT | Sb Lucius, Inc. | 2003-03-10 | 84 | 0 |
| K024143 | AIGIS-FINE | Sb Lucius, Inc. | 2003-03-10 | 84 | 0 |
| K024135 | AIGIS-PLUS | Sb Lucius, Inc. | 2003-03-10 | 84 | 0 |
| K024142 | AIGIS-SUPER | Sb Lucius, Inc. | 2003-03-10 | 84 | 0 |
| K024145 | AIGIS-XO | Sb Lucius, Inc. | 2003-03-07 | 81 | 0 |
| K024139 | AIGIS-INLAY | Sb Lucius, Inc. | 2003-03-07 | 81 | 0 |
| K024144 | AIGIS-PT | Sb Lucius, Inc. | 2003-03-07 | 81 | 0 |
| K024141 | NEO 76 | Sb Lucius, Inc. | 2003-03-06 | 80 | 0 |
| K024140 | AIGIS-A | Sb Lucius, Inc. | 2003-03-06 | 80 | 0 |
| K023197 | CERANUM 82 | Sb Lucius, Inc. | 2002-11-05 | 41 | 0 |
| K023200 | CERANUM 76 | Sb Lucius, Inc. | 2002-11-04 | 40 | 0 |
| K023199 | CERANUM 50 | Sb Lucius, Inc. | 2002-11-04 | 40 | 0 |
| K023196 | LUCIUS 76 | Sb Lucius, Inc. | 2002-11-01 | 37 | 0 |
| K023198 | CERANUM 90 | Sb Lucius, Inc. | 2002-11-01 | 37 | 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