Diversatek Healthcare
FDA Regulatory Profile
Diversatek Healthcare appears in FDA public data with 7 recalls, 4 510(k) clearances, 6 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1941-2026, Class II) was initiated on March 18, 2026. Its most recent 510(k) clearance was granted on April 25, 2023.
Summary
- Total Recalls
- 7
- 510(k) Clearances
- 4
- Inspections
- 6
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1941-2026 | Class II | Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator, 18mm-19mm-20mm, REF 1205-20 | March 18, 2026 |
| Z-1940-2026 | Class II | Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator, 15mm-16.5mm-18mm, REF 1205-18 | March 18, 2026 |
| Z-1939-2026 | Class II | Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator, 12mm-13.5mm-15mm, REF 1205-15 | March 18, 2026 |
| Z-1938-2026 | Class II | Diversatek Healthcare Viper¿ 3-Stage Fixed Wire Balloon Dilator, 6mm-7mm-8mm, REF 1204-08 | March 18, 2026 |
| Z-2324-2025 | Class III | Zvu Anorectal Manometry Procedure Kit, REF: HRAM-PROC-10 | June 4, 2025 |
| Z-2521-2023 | Class III | ZVU Functional GI Software, REF: ZVU-3 | July 25, 2023 |
| Z-1771-2022 | Class II | Diversatek Health, M-Catch Retrieval Nets, Part Number REF 1175-01, Quantity 5 EA/u. Used to endos | October 29, 2021 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K230056 | MiVu Esophageal Endo Cap | April 25, 2023 |
| K222734 | Diversatek Healthcare PureFlo Irrigation System / Water Bottle Tubing | November 8, 2022 |
| DEN180067 | Mucosal Integrity Conductivity (MI) Test System | December 23, 2019 |
| K190208 | Diversatek Healthcare High Resolution Impedance Manometry (HRiM) Probe | October 3, 2019 |