Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
PTD · Predicate Candidate Screening
3 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K192291 | TidalPort-AP Implantable Apheresis Vascular Access Port | Norfolk Medical Products, Inc. | 2020-08-20 | 363 | 0 |
| K191143 | PowerFlow Implantable Apheresis IV Port | C.R. Bard, Inc. | 2019-08-02 | 94 | 0 |
| K163001 | PowerFlow Apheresis I.V. Port | C.R. Bard, Inc. | 2017-04-17 | 171 | 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