510(k) Report

FDA applicant

Capnostics, LLC

Concord, NC1 decision2021–20212 recalls

FDA records 1 decision for Capnostics, LLC (Concord, NC) in 2021: 1 510(k) clearance. All are in product code EOX (Esophagoscope (Flexible Or Rigid)). Its devices cite 4 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, ear, nose and throat panel, where it files most

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

FDA decisions per year

1in 2021

2021: 1
2021high 1 (2021) · low 0 (2022)2026

2026 so far, outlined.

Recalls per year

2in 2024

2024: 2
2021high 2 (2024) · low 0 (2021)2026

Class I Class II/III not classified

FIG. 1 — Capnostics, LLC by year, 2021–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • EOXEsophagoscope (Flexible Or Rigid)1decision

Whose devices does it build on?

Its devices cite 4 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K203450EsophaCap Swallowable Cellular Retrieval Device (changed from Cell-Mata)Capnostics, LLC · 20212 recalls

The one decision as Capnostics, LLC →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K203450Brand Name: EsophaCap Product Name: EsophaCap (25mm diameter, 10 pores/inch)…Apr 24, 2024Class II
  • K203450Brand Name: EsophaCap Product Name: EsophaCap (20mm diameter, 20 pores/inch)…Apr 24, 2024Class II