Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
PWH — Predicate Candidate Screening
4 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K221319 | BD Alaris™ Pump Epidural Infusion Set | Care Fusion | 2023-07-21 | 441 | 0 |
| K211649 | PCEA Syringe Set | Baxter Healthcare Corporation | 2021-11-23 | 179 | 0 |
| K172592 | CADD Yellow High Volume Administration Set with NRFit connec | Smiths Medical Asd, Inc. | 2018-05-17 | 261 | 0 |
| K162219 | CADD® Infusion Disposables Portfolio with NRFit™ connectors | Smiths Medical Asd, Inc. | 2017-07-20 | 346 | 1 |
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