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510(k) K163334

LiDCOunity v2 Hemodynamic Monitor by Lidco, Ltd. — Product Code DXG

K163334 is an FDA 510(k) premarket notification submitted by Lidco, Ltd. for the device "LiDCOunity v2 Hemodynamic Monitor". The FDA issued a decision of Substantially Equivalent on June 5, 2017. The device falls under product code DXG (Computer, Diagnostic, Pre-Programmed, Single-Function), a Class II device regulated under 21 CFR 870.1435. Lidco, Ltd. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 5, 2017
Date Received
November 28, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Computer, Diagnostic, Pre-Programmed, Single-Function
Device Class
Class II
Regulation Number
870.1435
Review Panel
CV
Submission Type

Other clearances by Lidco, Ltd.

  • K152935 — LiDCOunity Monitor (March 17, 2016)
  • K131048 — LIDCO CNAP MODULE (August 28, 2013)
  • K122247 — LIDCORAPID V2 MONITOR (March 20, 2013)
  • K023960 — LIDCOPLUS HEMODYNAMIC MONITOR SYSTEM, MODEL HM 70 (January 9, 2003)
  • K010049 — PULSECO HEMODYNAMIC MONITOR CM71 (June 14, 2001)
  • K962918 — LIDCO SYSTEM (January 8, 1999)

Other clearances for product code DXG

  • K253092 — Argos Infinity (Rev. 1.0) (February 13, 2026)
  • K251275 — VitalStream ART Connect; VitalStream-Hemo (September 26, 2025)
  • K232048 — Cogent™ Hemodynamic Monitoring System; Cogent™ HMS (December 20, 2023)
  • K212529 — Hypotension Decision Assist Model HDA-OR2 (November 23, 2021)
  • K192169 — PulsioFlex Monitoring System with ProAQT Sensor (April 30, 2020)
  • K193179 — EV1000 Clinical Platform (December 17, 2019)
  • K190955 — Hypotension Decision Assist (November 27, 2019)
  • K181372 — Argos (December 13, 2018)
  • K172259 — PulsioFlex Monitoring System (January 18, 2018)
  • K152935 — LiDCOunity Monitor (March 17, 2016)

FDA data resources