Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Chip Ideas Electronics S.L. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
152 daysmedian FDA review time
351 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K211779 | ES001 Digital stethoscope for general-purpose auscultation, | Chip Ideas Electronics S.L. | 2022-05-26 | 351 | 0 |
| K212013 | eKuore Pro 4T - REF EP0098 | Chip Ideas Electronics S.L. | 2021-11-10 | 135 | 0 |
| K201742 | eKuore One Wireless Electronic Interface for stethoscope | Chip Ideas Electronics S.L. | 2020-11-24 | 152 | 0 |
| K203007 | eKuore Pro Series | Chip Ideas Electronics S.L. | 2020-10-30 | 29 | 0 |
| K181882 | eKuore One electronic interface for stethoscope | Chip Ideas Electronics S.L. | 2019-03-27 | 257 | 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