Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Am USA — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K133685 | 0.9% SODIUM CHLORIDE FLUSH SYRINGE | Am USA | 2014-08-13 | 254 | 1 |
| K120836 | 0.9% SODIUM CHLORIDE FLISH SYRINGE | Am USA | 2012-07-12 | 114 | 2 |
| K113555 | AM USA 0.9% SODIUM CHLORIDE FLUSH SYRINGE | Am USA | 2012-01-30 | 60 | 1 |
| K111034 | AM USA 0.9% SODIUM CHLORIDE FLUSH SYRINGE | Am USA | 2011-07-14 | 92 | 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