510(k) Report

FDA applicant

Csd Labs GmbH

Graz, AT3 decisions2019–20250 recalls

FDA records 3 decisions for Csd Labs GmbH (Graz, AT) from 2019 to 2025: 3 510(k) clearances. All are in product code DQD (Stethoscope, Electronic). Since 2016 its 510(k)s took a median of 150 days from receipt to decision, against 203 for FDA’s reviews in the same codes and years. Its devices cite 3 predicates, 2 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Csd Labs”.

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 Csd Labs GmbH’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2019: 12022: 12025: 1
2019high 1 (2019) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2019.

FIG. 1 — Csd Labs GmbH by year, 2019–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

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Which product codes does it file in?

  • DQDStethoscope, Electronic3decisions

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 150 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 203 days; 1 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 3 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 times; 2 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K181988eMurmur IDCsd Labs GmbH · 20193cite it
  • K220766eMurmur Heart AICsd Labs GmbH · 20221cites it

What has FDA decided for it lately?

  • K252284eMurmur Heart AICsd Labs · 2025
  • K220766eMurmur Heart AICsd Labs GmbH · 2022
  • K181988eMurmur IDCsd Labs GmbH · 2019

All 2 as Csd Labs GmbH →The one decision as Csd Labs →