Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medxl, Inc. · 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) |
|---|---|---|---|---|---|
| K233623 | Praxiject™ SP 0.9% NaCl | Medxl, Inc. | 2024-02-27 | 106 | 0 |
| K231754 | Praxiject™ 0.9% NaCl | Medxl, Inc. | 2023-07-13 | 28 | 0 |
| K192414 | Praxiject 0.9% NaCl | Medxl, Inc. | 2020-02-13 | 162 | 0 |
| K171109 | Praxiject 0.9% NaCl | Medxl, Inc. | 2017-12-21 | 251 | 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