Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
Smith — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
50 daysmedian FDA review time
218 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K973747 | CONTROLLED TEMPERATURE CABINET SYSTEM | Smith | 1998-05-07 | 218 | 0 |
| K973748 | TEMPO AND TEMP H20 | Smith | 1998-03-10 | 160 | 0 |
| K972123 | PROTECTIVE RESTRAINT MODELS #302,440,750,850,AND905 | Smith | 1997-07-25 | 50 | 0 |
| K971092 | QA-ES | Smith | 1997-04-23 | 28 | 0 |
| K970555 | IL0292 DP ECHOPORT | Smith | 1997-03-17 | 32 | 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