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510(k) K172586

Vios Monitoring System™ Model 2050 by Vios Medical, Inc. — Product Code DRT

K172586 is an FDA 510(k) premarket notification submitted by Vios Medical, Inc. for the device "Vios Monitoring System™ Model 2050". The FDA issued a decision of Substantially Equivalent on June 22, 2018. The device falls under product code DRT (Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)), a Class II device regulated under 21 CFR 870.2300. Vios Medical, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 22, 2018
Date Received
August 28, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
Device Class
Class II
Regulation Number
870.2300
Review Panel
CV
Submission Type

Other clearances by Vios Medical, Inc.

  • K173107 — Vios Central Station Monitor Software, Vios Central Server Software (July 26, 2018)
  • K150992 — Vios Monitoring System (December 16, 2015)

Other clearances for product code DRT

  • K261286 — The Circadia C300 System (C300) (May 20, 2026)
  • K252676 — The Circadia C300 System (C300) (February 3, 2026)
  • K253388 — Sleepiz One+ (Model 2.5) (January 28, 2026)
  • K251364 — Sleepiz One+ (2.5) (July 29, 2025)
  • K234003 — The Circadia C200 System (May 30, 2024)
  • K232354 — Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central (March 22, 2024)
  • K231733 — Neteera 130H-Plus Vital Sign Monitoring Sensor (February 9, 2024)
  • K223163 — Sleepiz One+ (August 18, 2023)
  • K212143 — Neteera 130H/131H Vital Sign Monitoring Sensor (September 28, 2022)
  • K202138 — Cardiac Trigger Monitor (May 14, 2021)

FDA data resources