510(k) Report

FDA applicant

Picofemto, LLC

New York, NY2 decisions2015–20160 recalls

FDA records 2 decisions for Picofemto, LLC (New York, NY) from 2015 to 2016: 2 510(k) clearances. Most are in product codes OMB (Automatic Event Detection Software For…) and LLZ (System, Image Processing, Radiological). Its devices cite 2 predicates, 0 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, neurology panel, where it files most

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

FDA decisions per year

1in 2016

2015: 12016: 1
2015high 1 (2015) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2015.

FIG. 1 — Picofemto, LLC by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • OMBAutomatic Event Detection Software For Full-Montage Electroencephalograph1decision
  • LLZSystem, Image Processing, Radiological1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K153593CliniscanSM MRIPicofemto, LLC · 2016
  • K141883Cliniscansm EegPicofemto, LLC · 2015

All 2 as Picofemto, LLC →