510(k) Report

FDA applicant

Medex, Inc.

Hilliard, OH50 decisions1977–202548 recalls

FDA records 50 decisions for Medex, Inc. (Hilliard, OH) from 1977 to 2025: 50 510(k) clearances. Most are in product codes FPA (Set, Administration, Intravascular) and DRS (Transducer, Blood-Pressure, Extravascular). Its devices cite 11 predicates, 3 of them its own earlier devices. 48 recalls are linked to its devices, 4 Class I.

FDA’s records also spell it “Medex”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general hospital panel, where it files most

How often FDA has decided Medex, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2022: 12025: 1
2007high 1 (2022) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

5in 2024

2007: 32008: 32009: 22010: 22012: 12013: 12015: 12017: 32018: 12020: 2, 2 Class I2021: 52022: 1, 1 Class I2023: 15, 1 Class I2024: 5
2007high 15 (2023) · low 0 (2011)2026

Class I Class II/III not classified

FIG. 1 — Medex, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Medex, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • FPASet, Administration, Intravascular9decisions
  • DRSTransducer, Blood-Pressure, Extravascular7decisions
  • FRNPump, Infusion6decisions
  • FMGStopcock, I.V. Set4decisions
  • KRACatheter, Continuous Flush3decisions
  • KXOMonitor, Pressure, Intrauterine3decisions

Also: MAV (2), DQO (2), GWM (2), FPB (2), FMF (2), DPW (1).

Whose devices does it build on?

Its devices cite 11 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 20 times; 3 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K040899Medex 3000 Series MR Syringe Infusion PumpMedex, Inc. · 20043cite it
  • K800560MX820-5 Pressure Infusor 500CC MX820-10Medex, Inc. · 19803cite it
  • K955231Medfusion Model 2001 Syringe Infusion PumpMedex, Inc. · 19962cite it
  • K951129Novatrans IIMedex, Inc. · 19952cite it
  • K982640Medex 3000 Series Syringe Infusion PumpMedex, Inc. · 19992cite it
  • K961404MX960 Reusable Pressure TransducerMedex, Inc. · 19962cite it

What has FDA decided for it lately?

  • K242255Qitexio® 4-Way Stopcock (QIT014)Medex · 2025
  • K203738QitexioMedex · 2022
  • K042432Pharmguard Toolbox, Model G6000782Medex, Inc. · 2005
  • K040899Medex 3000 Series MR Syringe Infusion PumpMedex, Inc. · 20044 Class I recalls
  • K020780Transtar Intracranial Pressure Transducer, Model MX950ICPMedex, Inc. · 20022 recalls
  • K000328Medex 3000 Series Mri Compatible Syringe Infusion PumpMedex, Inc. · 2000
  • K982640Medex 3000 Series Syringe Infusion PumpMedex, Inc. · 19991 recall
  • K982123Contrast Control DeviceMedex, Inc. · 1998

All 48 as Medex, Inc. →All 2 as Medex →

What has been recalled?

48 recalls linked to its devices; the latest:

  • K020780medex TranStar Single ICP Set 1/EA, Product Code REF MX20897Sep 24, 2024Class II
  • K942377medex NICU Monitoring Kit Set 1/EA, Product Code REF MX20086Sep 24, 2024Class II
  • K942377medex TRANSTAR MONITORING KIT 1/EA, Product Code REF MX20103R1Sep 24, 2024Class II
  • K942377medex TranStar Kit w/ Stopcock1/EA, Product Code REF MX20740Sep 24, 2024Class II
  • K020780medex TranStar Single OR Set 1/EA, Product Code REF MX20846R2Sep 24, 2024Class II
  • K040899smiths medical Medfusion Model 3500 Syringe pumpDec 19, 2023Class I