510(k) Report

FDA applicant

Gentuity, LLC

Sudbury, MA4 decisions2020–20251 recall

FDA records 4 decisions for Gentuity, LLC (Sudbury, MA) from 2020 to 2025: 4 510(k) clearances. Most are in product codes DQO (Catheter, Intravascular, Diagnostic) and NQQ (System, Imaging, Optical Coherence Tomography…). Its devices cite 5 predicates, 3 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, cardiovascular panel, where it files most

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

FDA decisions per year

1in 2025

2020: 12023: 12024: 12025: 1
2020high 1 (2020) · low 0 (2021)2026

2026 so far, outlined.

Recalls per year

1in 2026

2026 (partial year): 1
2020high 1 (2026) · low 0 (2020)2026

Class I Class II/III not classified

FIG. 1 — Gentuity, LLC by year, 2020–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Gentuity, 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?

  • DQOCatheter, Intravascular, Diagnostic2decisions
  • NQQSystem, Imaging, Optical Coherence Tomography (Oct)2decisions

Whose devices does it build on?

Its devices cite 5 predicates; 3 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K242239HF-OCT Imaging System with Vis-RX Micro-Imaging Catheter (G10 (HF-OCT Console), G30 (Vis-Rx Micro-Imaging…Gentuity, LLC · 20241cites it
  • K230620Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging CatheterGentuity, LLC · 20231cites it
  • K192922Gentuity HF-OCT Imaging System with Vis-Rx Micro-Imaging CatheterGentuity, LLC · 20201cites it

What has FDA decided for it lately?

  • K242966Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging CatheterGentuity, LLC · 20251 recall
  • K242239HF-OCT Imaging System with Vis-RX Micro-Imaging Catheter (G10 (HF-OCT Console), G30 (Vis-Rx Micro-Imaging…Gentuity, LLC · 2024
  • K230620Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging CatheterGentuity, LLC · 2023
  • K192922Gentuity HF-OCT Imaging System with Vis-Rx Micro-Imaging CatheterGentuity, LLC · 2020

All 4 as Gentuity, LLC →

What has been recalled?

1 recall linked to its devices; the latest:

  • K242966Gentuity HF-OCT Imaging System Model G10-01; Software version 23.2.13;Mar 23, 2026Class II