Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Finapres Medical Systems B.V. · 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) |
|---|---|---|---|---|---|
| K173916 | Finapres Nova Noninvasive Hemodynamic Monitor | Finapres Medical Systems B.V. | 2018-11-06 | 319 | 0 |
| K160967 | Finapres Nova Noninvasive Hemodynamic Monitor | Finapres Medical Systems B.V. | 2017-04-18 | 377 | 0 |
| K141460 | FINAPRES NOVA NONINVASIVE HEMODYNAMIC MONITOR | Finapres Medical Systems B.V. | 2015-03-20 | 291 | 0 |
| K063111 | FINOMETER MODEL-2 WITH ACCESSORIES | Finapres Medical Systems B.V. | 2007-02-01 | 113 | 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