Vios Monitoring System Model 2050— 510(k) K172586
Substantially EquivalentVios Medical, Inc.
FDA 510(k) clearance K172586 for Vios Monitoring System Model 2050, Substantially Equivalent on 2018-06-22. Applicant: Vios Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Vios Medical, Inc.
- Product code
- Code DRT
- Device class
- Class 2
- Regulation
- 21 CFR 870.2300
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- St. Paul, MN, US
Recent devices under product code DRT
view allMore clearances from Vios Medical, Inc.
view allAdverse events under product code DRT
product code DRT- Death
- 4
- Total
- 4
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K172586
K-number listed on FDA's recall record- Z-1292-2025 — Vios Monitoring System Bedside Monitor Model BSM2050
- Z-1069-2025 — muRata Vios Monitoring System Model 2050; bedside cardiac monitor, including cardiotachometer and alarm rate
- Z-1169-2025 — Vios Monitoring System Bedside Monitor, Model BSM2050, Software Version Numbers 1.54.20 and 1.56.00
- Z-0956-2025 — muRata Vios Monitoring System Model 2050; bedside cardiac monitor, including cardiotachometer and alarm rate
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K172586.
Data sourced from openFDA. This site is unofficial and independent of the FDA.