# Diversatek Healthcare

- Location (FDA's records): Highlands Ranch, CO
- FDA decisions: 4 (2019–2023): 3 510(k) clearances and 1 De Novo grant
- Names in FDA's records: Diversatek Healthcare (3); Diversatek Healthcare, Inc. (1)
- Product codes: QIS (2), FFX (1), OCX (1)
- Predicates its devices cite: 5 (1 its own); citations of its devices by later devices: 2 (1 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- United States Endoscopy Group, Inc.: 3 (https://510kreport.com/company/united-states-endoscopy-group)
- Unisensor AG: 1 (https://510kreport.com/company/unisensor)

## Firms that cite its devices most
- Alandra Medical Sapi DE CV: 1 (https://510kreport.com/company/alandra-medical-sapi)

## Its most-cited devices
- DEN180067: Mucosal Integrity Conductivity (MI) Test System (2019), cited by 2

## Recent decisions
- K230056: MiVu™ Esophageal Endo Cap (Apr 25, 2023)
- K222734: Diversatek Healthcare PureFlo Irrigation System / Water Bottle Tubing (Nov 8, 2022)
- DEN180067: Mucosal Integrity Conductivity (MI) Test System (Dec 23, 2019)
- K190208: Diversatek Healthcare High Resolution Impedance Manometry (HRiM) Probe (Oct 3, 2019)

Source page: https://510kreport.com/company/diversatek-healthcare