Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Nephron Pharmaceuticals Corp. · 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) |
|---|---|---|---|---|---|
| K113033 | SODIUM CHLORDE INHALATION SOLUTION, 0.9% USP-3ML | Nephron Pharmaceuticals Corp. | 2012-06-19 | 251 | 0 |
| K120051 | SODIUM CHLORIDE INHALATION SOLUTION, 3%, 7%, AND 10%, USP-4M | Nephron Pharmaceuticals Corp. | 2012-04-20 | 105 | 2 |
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