510(k) Report

FDA applicant

Medegen Medical Manufacturing Services

Ontario, CA5 decisions2004–200824 recalls

FDA records 5 decisions for Medegen Medical Manufacturing Services (Ontario, CA) from 2004 to 2008: 5 510(k) clearances. Most are in product codes FPA (Set, Administration, Intravascular) and FMG (Stopcock, I.V. Set). Its devices cite 4 predicates, 0 of them its own earlier devices. 24 recalls are linked to its devices.

FDA’s records also spell it “Medegen Medical Manufacturing Services, Inc.”.

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 Medegen Medical Manufacturing Services’s devices, and how often a recall has named them.

FDA decisions per year

1in 2008

2008: 1
2007high 1 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2026

2011: 12012: 102014: 12017: 22022: 92026 (partial year): 1
2007high 10 (2012) · low 0 (2007)2026

Class I Class II/III not classified

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

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Which product codes does it file in?

  • FPASet, Administration, Intravascular3decisions
  • FMGStopcock, I.V. Set1decision
  • FMFSyringe, Piston1decision

Whose devices does it build on?

Its devices cite 4 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 times; 0 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.

  • K051499Intravascular Administration Set and Extension SetMedegen Medical Manufacturing Services · 20055cite it

What has FDA decided for it lately?

  • K083765Maxguard Advanced Luer Activated Device with AntimicrobialMedegen Medical Manufacturing Services · 2008
  • K052330Tru-Swab StocockMedegen Medical Manufacturing Services · 2005
  • K051930Drug Access SpikeMedegen Medical Manufacturing Services · 2005
  • K051499Intravascular Administration Set and Extension SetMedegen Medical Manufacturing Services · 200524 recalls
  • K041179Modification to the Nac Plus Needleless Access ConnectorMedegen Medical Manufacturing Services, Inc. · 2004

All 4 as Medegen Medical Manufacturing Services →The one decision as Medegen Medical Manufacturing Services, Inc. →

What has been recalled?

24 recalls linked to its devices; the latest:

  • K05149960 In Non-DEHP Minibore Extension Set RES ME2010 UDI-DI code: 10885403236235 MaxPlus Ext…Jun 16, 2026Class II
  • K051499BD MaxGuard Flow Controller Extension Set with Needleless Y-Site, REF: MFS106Aug 1, 2022Class II
  • K051499BD MaxGuard Extension Set with 1.2 Micron Filter and Needleless Y-Site, REF: MX9171Aug 1, 2022Class II
  • K051499BD MaxGuard Extension Set with 2 Needleless Y-Site, REF: MX9059Aug 1, 2022Class II
  • K051499BD MaxGuard Extension Set with 0.2 Micron Filter and Needleless Y-Site, REF: MX9166Aug 1, 2022Class II
  • K051499BD MaxGuard Extension Set, REF: ME1069Aug 1, 2022Class II

Other applicant names beginning “Medegen”

FDA records each applicant name separately; these may or may not be the same firm.

Medegen Medical Manufacturing System 2Medegen, Inc. 1