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510(k) K112448

PULSIOFLEX by Pulsion Medical Systems, Inc. — Product Code DXG

K112448 is an FDA 510(k) premarket notification submitted by Pulsion Medical Systems, Inc. for the device "PULSIOFLEX". The FDA issued a decision of Substantially Equivalent on September 22, 2011. The device falls under product code DXG (Computer, Diagnostic, Pre-Programmed, Single-Function), a Class II device regulated under 21 CFR 870.1435. Pulsion Medical Systems, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 22, 2011
Date Received
August 25, 2011
Clearance Type
Special
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 Pulsion Medical Systems, Inc.

  • K091786 — PULSION PICCO2 (8500), CEVOX OPTICAL MODULE (PC3015), CEVOX DISPOSABLE PROBES ( (June 18, 2010)
  • K072735 — PULSION PICCO-2, MODEL 8500 (October 18, 2007)
  • K072364 — PULSION PULSIOCATH THERMODILUTION CATHETERS & ACCESSORIES (September 19, 2007)
  • K060898 — PULSION PICCO PLUS, MODEL 8100 (July 25, 2006)
  • K020587 — PULSION PULSIOCATH PICCO MONITORING KIT, INJECTATE SENSOR TEMPERATURE HOUSING PV (May 23, 2002)
  • K001762 — PULSION CONTINUOUS PULSE CONTOUR CARDIAC OUTPUT (PICCO) SYSTEM (June 13, 2000)
  • K991886 — PULSION PULSIOCATH, PULSION PCCO MONITORING KIT, PULSION IN-LINE INJECTATE SENSO (May 11, 2000)

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)
  • K163334 — LiDCOunity v2 Hemodynamic Monitor (June 5, 2017)

FDA data resources