Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Steridyne Corp. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
35 daysmedian FDA review time
82 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K925352 | CLEAN CUFF BLOOD PRESSURE CUFF LINER | Steridyne Corp. | 1993-01-12 | 82 | 0 |
| K911843 | ZERO-G(TM) GEL/FOAM MATTRESS TOPPER | Steridyne Corp. | 1991-05-30 | 35 | 0 |
| K911269 | MERCURY AND GLASS FEVER THERMOMETER | Steridyne Corp. | 1991-05-15 | 54 | 0 |
| K842120 | ZERO-G | Steridyne Corp. | 1984-06-08 | 10 | 0 |
| K821314 | FEVER METER | Steridyne Corp. | 1982-05-28 | 24 | 0 |
| K801458 | WINTER HEAD DRESSING | Steridyne Corp. | 1980-07-28 | 34 | 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