Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Phenox Limited — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K242676 | pRESET Delta Thrombectomy Device and pRESET Delta LITE Throm | Phenox Limited | 2025-02-28 | 175 | 0 |
| K231539 | pRESET LITE Thrombectomy Device | Phenox Limited | 2023-10-21 | 144 | 0 |
| K222848 | pRESET Thrombectomy Device | Phenox Limited | 2023-01-20 | 121 | 0 |
| K191687 | pORTAL Steerable Hydrophilic Guidewire and pORTAL EXT Extens | Phenox Limited | 2019-10-09 | 107 | 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