510(k) Report

FDA applicant

I2s Micro Implantable Systems, LLC

Stoughton, WI1 decision2009–20092 recalls

FDA records 1 decision for I2s Micro Implantable Systems, LLC (Stoughton, WI) in 2009: 1 510(k) clearance. All are in product code GWL (Amplifier, Physiological Signal). 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, neurology panel, where it files most

How often FDA has decided I2s Micro Implantable Systems, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2009

2009: 1
2009high 1 (2009) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

2in 2016

2016: 2
2009high 2 (2016) · low 0 (2009)2026

Class I Class II/III not classified

FIG. 1 — I2s Micro Implantable Systems, LLC by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • GWLAmplifier, Physiological Signal1decision

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 3 times; 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.

  • K090957Blackrock Neuroport Biopotential Signal Processing SystemI2s Micro Implantable Systems, LLC · 20093cite it

What has FDA decided for it lately?

  • K090957Blackrock Neuroport Biopotential Signal Processing SystemI2s Micro Implantable Systems, LLC · 20092 recalls

The one decision as I2s Micro Implantable Systems, LLC →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K090957Neural Signal Amplifier. Part Numbers: 4208, 5703, 5749, 5748, 5747. Product Usage: The…Aug 10, 2016Class II
  • K090957Patient Cable. Part Numbers: 4460, 6735. Sterile within Chipboard Boxes within…Aug 10, 2016Class II