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510(k) K242255

Qitexio® 4-Way Stopcock (QIT014) by Medex — Product Code FMG

K242255 is an FDA 510(k) premarket notification submitted by Medex for the device "Qitexio® 4-Way Stopcock (QIT014)". The FDA issued a decision of Substantially Equivalent on April 29, 2025. The device falls under product code FMG (Stopcock, I.V. Set), a Class II device regulated under 21 CFR 880.5440. Medex has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 29, 2025
Date Received
July 31, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stopcock, I.V. Set
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type

Other clearances by Medex

  • K203738 — Qitexio (March 14, 2022)
  • K042432 — PHARMGUARD TOOLBOX, MODEL G6000782 (January 4, 2005)
  • K040899 — MEDEX 3000 SERIES MR SYRINGE INFUSION PUMP (April 30, 2004)
  • K020780 — TRANSTAR INTRACRANIAL PRESSURE TRANSDUCER, MODEL MX950ICP (May 20, 2002)
  • K000328 — MEDEX 3000 SERIES MRI COMPATIBLE SYRINGE INFUSION PUMP (May 9, 2000)
  • K982640 — MEDEX 3000 SERIES SYRINGE INFUSION PUMP (April 6, 1999)
  • K982123 — CONTRAST CONTROL DEVICE (July 21, 1998)
  • K955231 — MEDFUSION MODEL 2001 SYRINGE INFUSION PUMP (July 18, 1996)
  • K961404 — MX960 REUSABLE PRESSURE TRANSDUCER (June 27, 1996)
  • K961527 — MX703 AND MX730 CONTINUOUS FLUSH DEVICES (June 6, 1996)

Other clearances for product code FMG

  • K223499 — Three Way Stop Cock (July 21, 2023)
  • K223175 — lntravascular Administration Sets with Stopcock and Manifold (March 10, 2023)
  • K211204 — SafePort(TM) Manifold (or Stopcock) (September 15, 2022)
  • K210516 — Clicky Cross (May 16, 2022)
  • K190539 — TurnSignal Stopcocks Sterile, TurnSignal Stopcocks Buld Non Sterile, TurnSignal (October 22, 2019)
  • K190489 — Elcam Stopcocks and Manifolds (April 23, 2019)
  • K172266 — Dynarex Three-Way Stopcock (March 14, 2018)
  • K141254 — ELCAM STOPCOCKS AND MANIFOLDS (July 30, 2014)
  • K123084 — DISPOSABLE HIGH PRESSURE STOPCOCK/MANIFOLD MODEL HP STOPCOCK, MP STOPCOCK, HP MA (May 23, 2013)
  • K130245 — LARGE BORE STOPCOCK WITH ROTATING MALE LUER LOCK/LARGE BORE STOPCOCK WITH EXTENS (March 1, 2013)

FDA data resources