510(k) Report

FDA applicant

Eresearchtechnology GmbH

Estenfeld, DE3 decisions2019–20240 recalls

FDA records 3 decisions for Eresearchtechnology GmbH (Estenfeld, DE) from 2019 to 2024: 3 510(k) clearances. All are in product code BTY (Calculator, Predicted Values, Pulmonary Function). Its devices cite 3 predicates, 1 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, anesthesiology panel, where it files most

How often FDA has decided Eresearchtechnology GmbH’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2019: 12021: 12024: 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 — Eresearchtechnology GmbH by year, 2019–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • BTYCalculator, Predicted Values, Pulmonary Function3decisions

Whose devices does it build on?

Its devices cite 3 predicates; 1 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.

  • K202754MasterScope, MasterScope CT, MasterScope ECG, MasterScope WSSUEresearchtechnology GmbH · 20211cites it

What has FDA decided for it lately?

  • K223629SpiroSphere, SpiroSphereECG, CardioSphereEresearchtechnology GmbH · 2024
  • K202754MasterScope, MasterScope CT, MasterScope ECG, MasterScope WSSUEresearchtechnology GmbH · 2021
  • K173937SpiroSphereEresearchtechnology GmbH · 2019

All 3 as Eresearchtechnology GmbH →