Chip Ideas Electronics S.L.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Chip Ideas Electronics S.L.” (first 2019, latest 2022), across 1 product code in 1 review panel. Median 510(k) review time under this name: 152 days. Since 2017 the median was 152 days, against 144 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2019 | 1 | 257 |
| 2020 | 2 | 90 |
| 2021 | 1 | 135 |
| 2022 | 1 | 351 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Chip Ideas Electronics S.L. took a median 152 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 144 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DQD | Stethoscope, Electronic | 5 | 5 |
Review panels
- Cardiovascular (5)
Most recent Chip Ideas Electronics S.L. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K211779 | ES001 Digital stethoscope for general-purpose auscultation, ES002 Digital stethoscope for hearing impaired users, ES003 Digital stethoscope for telemedicine. | DQD | 2022-05-26 | 351 |
| K212013 | eKuore Pro 4T - REF EP0098 | DQD | 2021-11-10 | 135 |
| K201742 | eKuore One Wireless Electronic Interface for stethoscope | DQD | 2020-11-24 | 152 |
| K203007 | eKuore Pro Series | DQD | 2020-10-30 | 29 |
| K181882 | eKuore One electronic interface for stethoscope | DQD | 2019-03-27 | 257 |
Recalls
openFDA lists no recalls under a recalling firm named Chip Ideas Electronics S.L..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Chip Ideas Electronics S.L.?
FDA lists 5 510(k) clearances under the applicant name “Chip Ideas Electronics S.L.” (first 2019, latest 2022), across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Chip Ideas Electronics S.L.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Chip Ideas Electronics S.L. is 152 days. Since 2017: 152 days, versus 144 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Chip Ideas Electronics S.L.?
The most frequent FDA product codes under this applicant name are DQD (Stethoscope, Electronic, 5).
Next steps
- See all 5 Chip Ideas Electronics S.L. clearances with predicates and recalls
- Run predicate analysis for product code DQD, Chip Ideas Electronics S.L.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.