Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Esaote Biomedica Spa · 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) |
|---|---|---|---|---|---|
| K933951 | VIDEO EEG OPTION MODIFICATION | Esaote Biomedica Spa | 1994-02-03 | 175 | 0 |
| K902368 | PERSONAL 120/210 BASIC ELECTROCARDIOGRAPH | Esaote Biomedica Spa | 1990-09-11 | 105 | 0 |
| K896356 | AU530 DIAGNOSTIC ULTRASONIC PULSED ECHO SYSTEM | Esaote Biomedica Spa | 1990-08-21 | 288 | 0 |
| K902334 | MONITOR, MODEL 2817 | Esaote Biomedica Spa | 1990-06-26 | 33 | 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