Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Baxter Bentley Laboratories, Inc. — 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) |
|---|---|---|---|---|---|
| K905312 | DURAFLO II HEPARIN TREATED FEMORAL CANNULAE MODELS | Baxter Bentley Laboratories, Inc. | 1991-01-15 | 48 | 0 |
| K905311 | DURAFLO II HEPARIN TREATED SUCTION WANDS VAR. MOD. | Baxter Bentley Laboratories, Inc. | 1991-01-15 | 48 | 0 |
| K882892 | MEMBRANE OXYGENATOR | Baxter Bentley Laboratories, Inc. | 1988-09-27 | 78 | 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