Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Feops NV — 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) |
|---|---|---|---|---|---|
| K250635 | FEops HEARTguide Simulation Application | Feops NV | 2025-11-25 | 267 | 0 |
| K223855 | FEops HEARTguideTM, FEops HEARTguideTM ALPACA | Feops NV | 2023-06-06 | 165 | 0 |
| K214066 | FEops HEARTguide | Feops NV | 2022-02-25 | 60 | 0 |
| DEN200030 | FEops HEARTguide | Feops NV | 2021-09-08 | 489 | 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