Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Scieran Technologies, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
104 daysmedian FDA review time
206 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K974253 | CPD COMMANDER | Scieran Technologies, Inc. | 1998-02-25 | 104 | 0 |
| K980085 | PHACO COMMANDER | Scieran Technologies, Inc. | 1998-02-24 | 46 | 0 |
| K973749 | FRAG COMMANDER | Scieran Technologies, Inc. | 1997-12-08 | 68 | 0 |
| K961738 | VIT COMMANDER SYSTEM | Scieran Technologies, Inc. | 1996-11-25 | 206 | 0 |
| K960767 | LIGHT COMMANDER | Scieran Technologies, Inc. | 1996-08-26 | 182 | 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