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510(k) K203738

Qitexio by Medex — Product Code FMF

K203738 is an FDA 510(k) premarket notification submitted by Medex for the device "Qitexio". The FDA issued a decision of Substantially Equivalent on March 14, 2022. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. Medex has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 14, 2022
Date Received
December 22, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Syringe, Piston
Device Class
Class II
Regulation Number
880.5860
Review Panel
HO
Submission Type

Other clearances by Medex

  • K242255 — Qitexio® 4-Way Stopcock (QIT014) (April 29, 2025)
  • 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 FMF

  • K260208 — Ultra-Fine™ SAFETY Insulin Syringe (July 13, 2026)
  • K253110 — Sol-Glide Safety Needle; Sol-Glide Safety Needle with Syringe (June 18, 2026)
  • K260514 — Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™ Low (June 12, 2026)
  • K253112 — Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); (May 21, 2026)
  • K252279 — Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml) (April 17, 2026)
  • K253068 — Profoject™ Insulin Syringes; Profoject™ Safelock Disposable Insulin Syringe (February 23, 2026)
  • K253769 — Instylla Delivery Kit (December 22, 2025)
  • K252518 — DuoprossTM Smart Cap (Type I) (December 17, 2025)
  • K251089 — EXEL Disposable Syringe; EXEL Disposable Syringe with Needle; EXEL Disposable Sy (December 12, 2025)
  • K250192 — Verisafe Safety Retractable Insulin Syringes (December 10, 2025)

FDA data resources