Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Baxter Healthcare Corportation · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K233441 | The Vest APX System (PVAPX1) | Baxter Healthcare Corportation | 2024-03-22 | 156 | 0 |
| K201809 | AK 98 Dialysis Machine, U9000 Ultrafilter, C705 Expansion Ch | Baxter Healthcare Corportation | 2021-03-10 | 252 | 0 |
| K193137 | EASYGRIP FLO-41 Precision MIS Delivery System | Baxter Healthcare Corportation | 2020-01-08 | 56 | 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