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510(k) K141193

MEDFUSION 4000 PUMP DEVICE SPECIFIC REPORTS SOLFWARE FOR PHARMGUARD SERVER VERSION 2.0 by Smiths Medical Asd, Inc. — Product Code PHC

K141193 is an FDA 510(k) premarket notification submitted by Smiths Medical Asd, Inc. for the device "MEDFUSION 4000 PUMP DEVICE SPECIFIC REPORTS SOLFWARE FOR PHARMGUARD SERVER VERSION 2.0". The FDA issued a decision of Substantially Equivalent on July 25, 2014. The device falls under product code PHC (Infusion Safety Management Software), a Class II device regulated under 21 CFR 880.5725. Smiths Medical Asd, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 25, 2014
Date Received
May 8, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Infusion Safety Management Software
Device Class
Class II
Regulation Number
880.5725
Review Panel
HO
Submission Type

Infusion safety management software is a prescription device intended for use with infusion pumps and may include one or more of the following capabilities: prepopulation of infusion programming parameters, data retrieval and analysis for tracking and trending, drug infusion error reduction algorithms, and alarm transmission.

Other clearances by Smiths Medical Asd, Inc.

  • K232943 — Hypodermic Needle-Pro® EDGE™ Safety Device with Low Dead Space Syringe (May 31, 2024)
  • K210833 — Portex BLUxl Extra Length Tracheostomy Tube, BLUxl Suctionaid Extra Length Trach (November 26, 2021)
  • K211634 — Hypodermic Needle-Pro EDGE Safety Device (August 26, 2021)
  • K192375 — Intellifuse Administration and Intellifuse Blood Administration Sets (September 18, 2020)
  • K181699 — Level 1 Convective Warmer (July 26, 2018)
  • K172800 — Portex® Lancet Point Spinal Needles with NRFit™ connectors, Portex® Pencil Point (June 14, 2018)
  • K172823 — Portex NRFit Epidural Needles (June 12, 2018)
  • K172410 — Portex NRFit Epidural Needles, Portex NRFit Spinal Needles, Portex NRFit Loss of (June 1, 2018)
  • K172592 — CADD Yellow High Volume Administration Set with NRFit connector (May 17, 2018)
  • K173912 — BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUperc Perc (May 8, 2018)

Other clearances for product code PHC

  • K252130 — LifeShield Infusion Safety Software Suite (April 2, 2026)
  • K243062 — BD Intelliport System; BD Intelliport Reader (516230); BD Intelliport Sensor (51 (June 20, 2025)
  • K242117 — LifeShield Infusion Safety Software Suite (April 2, 2025)
  • K230665 — Dose IQ Safety Software (March 29, 2024)
  • K223606 — LifeShield™ Infusion Safety Software Suite (August 24, 2023)
  • K211124 — Dose IQ Safety Software (August 30, 2022)
  • K210075 — Vigilant Software Suite – Vigilant Master Med (March 1, 2022)
  • K182092 — BD Intelliport System (April 30, 2019)
  • K141474 — BECTON DICKINSON INTELLIPORT SYSTEM (December 18, 2014)

FDA data resources