Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Steripak, Ltd. · Predicate Candidate Screening
2 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K980829 | 3ML STERI-NEB SALINE - 0.9% W/V SODIUM CHLORIDE INHALATION S | Steripak, Ltd. | 1998-06-02 | 90 | 0 |
| K972185 | 20 ML NORMAL SALINE TOPICAL SOLUTION, 0.9% W/V SODIUM CHLORI | Steripak, Ltd. | 1998-03-05 | 268 | 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