510(k) Report

FDA applicant

Chip Ideas Electronics S.L.

Burjasot, ES5 decisions2019–20220 recalls

FDA records 5 decisions for Chip Ideas Electronics S.L. (Burjasot, ES) from 2019 to 2022: 5 510(k) clearances. All are in product code DQD (Stethoscope, Electronic). Since 2016 its 510(k)s took a median of 152 days from receipt to decision, against 137 for FDA’s reviews in the same codes and years. Its devices cite 6 predicates, 3 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Chip Ideas Electronics S.L.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2019: 12020: 22021: 12022: 1
2019high 2 (2020) · low 0 (2023)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2019.

FIG. 1 — Chip Ideas Electronics S.L. by year, 2019–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Chip Ideas Electronics S.L.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • DQDStethoscope, Electronic5decisions

How long do its 510(k) reviews take?

Since 2016, its 5 510(k)s took a median of 152 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 137 days; 3 of its 5 were faster than that.

Whose devices does it build on?

Its devices cite 6 predicates; 3 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K203007eKuore Pro SeriesChip Ideas Electronics S.L. · 20202cite it
  • K181882eKuore One electronic interface for stethoscopeChip Ideas Electronics S.L. · 20191cites it

What has FDA decided for it lately?

  • K211779ES001 Digital stethoscope for general-purpose auscultation, ES002 Digital stethoscope for hearing impaired…Chip Ideas Electronics S.L. · 2022
  • K212013eKuore Pro 4T - REF EP0098Chip Ideas Electronics S.L. · 2021
  • K201742eKuore One Wireless Electronic Interface for stethoscopeChip Ideas Electronics S.L. · 2020
  • K203007eKuore Pro SeriesChip Ideas Electronics S.L. · 2020
  • K181882eKuore One electronic interface for stethoscopeChip Ideas Electronics S.L. · 2019

All 5 as Chip Ideas Electronics S.L. →