510(k) Report

FDA applicant

Diversatek Healthcare

Highlands Ranch, CO4 decisions2019–20231 recall

FDA records 4 decisions for Diversatek Healthcare (Highlands Ranch, CO) from 2019 to 2023: 3 510(k) clearances and 1 De Novo grant. Most are in product codes QIS (Esophageal, Mucosal, Electrical Characterization) and FFX (System, Gastrointestinal Motility (Electrical)). Its devices cite 5 predicates, 1 of them its own earlier devices. 1 recall is linked to its devices.

FDA’s records also spell it “Diversatek Healthcare, Inc.”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, gastroenterology and urology panel, where it files most

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

FDA decisions per year

1in 2023

2019: 22022: 12023: 1
2019high 2 (2019) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

1in 2025

2025: 1
2019high 1 (2025) · low 0 (2019)2026

Class I Class II/III not classified

FIG. 1 — Diversatek Healthcare by year, 2019–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Diversatek Healthcare’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?

  • QISEsophageal, Mucosal, Electrical Characterization2decisions
  • FFXSystem, Gastrointestinal Motility (Electrical)1decision
  • OCXEndoscopic Irrigation/Suction System1decision

Whose devices does it build on?

Its devices cite 5 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 1 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.

  • DEN180067Mucosal Integrity Conductivity (MI) Test SystemDiversatek Healthcare, Inc. · 20192cite it

What has FDA decided for it lately?

  • K230056MiVu™ Esophageal Endo CapDiversatek Healthcare · 2023
  • K222734Diversatek Healthcare PureFlo Irrigation System / Water Bottle TubingDiversatek Healthcare · 2022
  • DEN180067Mucosal Integrity Conductivity (MI) Test SystemDiversatek Healthcare, Inc. · 2019
  • K190208Diversatek Healthcare High Resolution Impedance Manometry (HRiM) ProbeDiversatek Healthcare · 20191 recall

All 3 as Diversatek Healthcare →The one decision as Diversatek Healthcare, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K190208Zvu Anorectal Manometry Procedure Kit, REF: HRAM-PROC-10Jun 4, 2025Class III