510(k) Report

FDA applicant

Corscience GmbH & Co. KG

Monroeville, PA5 decisions2008–20201 recall

FDA records 5 decisions for Corscience GmbH & Co. KG (Monroeville, PA) from 2008 to 2020: 5 510(k) clearances. Most are in product codes DXH (Transmitters And Receivers…) and HCC (Device, Biofeedback). Its devices cite 11 predicates, 1 of them its own earlier devices. 1 recall is linked to its devices.

FDA’s records also spell it “Corscience GmbH & Co.”.

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

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

How often FDA has decided Corscience GmbH & Co. KG’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2008: 22012: 12018: 12020: 1
2008high 2 (2008) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

1in 2012

2012: 1
2008high 1 (2012) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — Corscience GmbH & Co. KG by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Corscience GmbH & Co. KG’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?

  • DXHTransmitters And Receivers, Electrocardiograph, Telephone1decision
  • HCCDevice, Biofeedback1decision
  • OLUNormalizing Quantitative Electroencephalograph Software1decision
  • GWQFull-Montage Standard Electroencephalograph1decision
  • DPSElectrocardiograph1decision

Whose devices does it build on?

Its devices cite 11 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 6 times; 1 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.

  • K082077BT3/6, BT12Corscience GmbH & Co. KG · 20083cite it
  • K073557Eeg Neuroamp, Model CS10137Corscience GmbH & Co. KG · 20082cite it
  • K112077Hbidb - Human Brian Index SoftwareCorscience GmbH & Co. KG · 20121cites it

What has FDA decided for it lately?

  • K193159NeuroAmp II, NeuroAmp II.5sCorscience GmbH & Co. KG · 2020
  • K183369COR12 EcgCorscience GmbH & Co. · 2018
  • K112077Hbidb - Human Brian Index SoftwareCorscience GmbH & Co. KG · 2012
  • K082077BT3/6, BT12Corscience GmbH & Co. KG · 2008
  • K073557Eeg Neuroamp, Model CS10137Corscience GmbH & Co. KG · 20081 recall

All 4 as Corscience GmbH & Co. KG →The one decision as Corscience GmbH & Co. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K073557EEG NeuroAmp, Model Number: CS 10090; CS 10137. Biofeedback and RelaxationNov 15, 2012Class II