Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Baxter Healthcare · 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) |
|---|---|---|---|---|---|
| K231849 | MiniCap Extended Life PD Transfer Set with Twist Clamp - Cod | Baxter Healthcare | 2024-03-12 | 263 | 0 |
| K192705 | MiniCap Extended Life PD Transfer Sets | Baxter Healthcare | 2019-10-25 | 28 | 2 |
| K152675 | EXTENDED LIFE CAPD TRANSFER SET, PERITONEAL DIALYSIS TITANIU | Baxter Healthcare | 2015-10-29 | 41 | 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