510(k) Report

FDA applicant

Spd Swiss Precision Diagnostics GmbH

Geneva, CH4 decisions2021–20242 recalls

FDA records 4 decisions for Spd Swiss Precision Diagnostics GmbH (Geneva, CH) from 2021 to 2024: 4 510(k) clearances. All are in product code LCX (Kit, Test, Pregnancy, Hcg, Over The Counter). Since 2016 its 510(k)s took a median of 343 days from receipt to decision, against 264 for FDA’s reviews in the same codes and years. Its devices cite 3 predicates, 0 of them its own earlier devices. 2 recalls are linked to its devices.

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

FIG. A — Illustration, clinical chemistry panel, where it files most

How often FDA has decided Spd Swiss Precision Diagnostics GmbH’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2021: 12022: 22024: 1
2021high 2 (2022) · low 0 (2023)2026

2026 so far, outlined.

Recalls per year

1in 2023

2022: 12023: 1
2021high 1 (2022) · low 0 (2021)2026

Class I Class II/III not classified

FIG. 1 — Spd Swiss Precision Diagnostics GmbH by year, 2021–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Spd Swiss Precision Diagnostics 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?

  • LCXKit, Test, Pregnancy, Hcg, Over The Counter4decisions

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 343 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 264 days; 1 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 0 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.

  • K213379Clearblue ® Early Pregnancy TestSpd Swiss Precision Diagnostics GmbH · 20221cites it

What has FDA decided for it lately?

  • K240025Clearblue® Early Detection Pregnancy TestSpd Swiss Precision Diagnostics GmbH · 2024
  • K213379Clearblue ® Early Pregnancy TestSpd Swiss Precision Diagnostics GmbH · 2022
  • K210341One Step Pregnancy TestSpd Swiss Precision Diagnostics GmbH · 2022
  • K200913Clearblue® Early Digital Pregnancy TestSpd Swiss Precision Diagnostics GmbH · 20212 recalls

All 4 as Spd Swiss Precision Diagnostics GmbH →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K200913Clearblue Smart Countdown Prgncy TST 1CT, Sku 900260Oct 4, 2023Class II
  • K200913Clearblue Smart Countdown Prgncy TST 1CT, Sku-ID 900260Jun 23, 2022Class II