510(k) Report

FDA applicant

Infinite Biomedical Technologies, LLC

Baltimore, MD6 decisions2008–20240 recalls

FDA records 6 decisions for Infinite Biomedical Technologies, LLC (Baltimore, MD) from 2008 to 2024: 6 510(k) clearances. Most are in product codes GXY (Electrode, Cutaneous) and OLT (Non-Normalizing Quantitative…). Since 2016 its 510(k)s took a median of 60 days from receipt to decision, against 135 for FDA’s reviews in the same codes and years. Its devices cite 7 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Infinite Biomedical Technologies”.

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 Infinite Biomedical Technologies, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2008: 12009: 12010: 12018: 22024: 1
2008high 2 (2018) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2008.

FIG. 1 — Infinite Biomedical Technologies, LLC by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Infinite Biomedical Technologies, LLC’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?

  • GXYElectrode, Cutaneous3decisions
  • OLTNon-Normalizing Quantitative Electroencephalograph Software2decisions
  • GWQFull-Montage Standard Electroencephalograph1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 60 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 135 days; 3 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 7 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 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.

  • K072382Model I-2000 MonitorInfinite Biomedical Technologies · 20082cite it
  • K240884Glide (91000-GL-X)Infinite Biomedical Technologies, LLC · 20241cites it
  • K182112Sense System with IBT ElectrodesInfinite Biomedical Technologies, LLC · 20181cites it

What has FDA decided for it lately?

  • K240884Glide (91000-GL-X)Infinite Biomedical Technologies, LLC · 2024
  • K182112Sense System with IBT ElectrodesInfinite Biomedical Technologies, LLC · 2018
  • K173571Element System with IBT ElectrodesInfinite Biomedical Technologies, LLC · 2018
  • K101386Vigilant Eeg Monitor Model Vigilant 2.0Infinite Biomedical Technologies, LLC · 2010
  • K091963Vigilant Eeg Monitor, Vigilant 2.0Infinite Biomedical Technologies, LLC · 2009
  • K072382Model I-2000 MonitorInfinite Biomedical Technologies · 2008

All 5 as Infinite Biomedical Technologies, LLC →The one decision as Infinite Biomedical Technologies →