510(k) Report

FDA applicant

Nanospere,Inc.

Northbrook, IL1 decision2014–20141 recall

FDA records 1 decision for Nanospere,Inc. (Northbrook, IL) in 2014: 1 510(k) clearance. All are in product code PCH (Gastrointestinal Pathogen Panel Multiplex…). Its devices cite 2 predicates, 0 of them its own earlier devices. 1 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, microbiology panel, where it files most

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

FDA decisions per year

1in 2014

2014: 1
2014high 1 (2014) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

1in 2018

2018: 1
2014high 1 (2018) · low 0 (2014)2026

Class I Class II/III not classified

FIG. 1 — Nanospere,Inc. by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • PCHGastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System1decision

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?

  • K142033Verigene Enteric Pathogen Nucleic Acid Test (EP)Nanospere,Inc. · 20141 recall

The one decision as Nanospere,Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K142033Verigene Enteric Pathogens Nucleic Acid Test (EP) for detecting and identification of…May 8, 2018Class II