510(k) Report

FDA applicant

Millipore Corp.

Milford, MA33 decisions1977–20101 recall

FDA records 33 decisions for Millipore Corp. (Milford, MA) from 1977 to 2010: 32 510(k) clearances and 1 original PMA approval. Most are in product codes LDM (Instrumentation, High Pressure Liquid…) and BSN (Filter, Conduction, Anesthetic). 1 recall is linked to its devices.

FDA’s records also spell it “Millipore Corporation”.

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

FIG. A — Illustration, clinical chemistry panel, where it files most

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

FDA decisions per year

1in 2010

2009: 12010: 1
2007high 1 (2009) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2009

2009: 1
2007high 1 (2009) · low 0 (2007)2026

Class I Class II/III not classified

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

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

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Which product codes does it file in?

  • LDMInstrumentation, High Pressure Liquid Chromatography7decisions
  • BSNFilter, Conduction, Anesthetic3decisions
  • JRLUnit, Filter, Membrane3decisions
  • KIEApparatus, High Pressure Liquid Chromatography3decisions
  • FIPSubsystem, Water Purification2decisions
  • FPBFilter, Infusion Line2decisions

Also: FIB (1), LKN (1), KPP (1), JJH (1), DPM (1), GLZ (1).

Who builds on its devices?

Later devices cite its devices 2 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.

  • K934069Millex, Dualex (Plus, Ultra)Millipore Corp. · 19941cites it
  • K023892Millex VV, GV, and HV Syringe Filter UnitsMillipore Corp. · 20031cites it

What has FDA decided for it lately?

  • K093815Light Diagnostics Human Metapneumovirus Dfa Kit, Model Catalog Number 3124Millipore Corporation · 2010
  • K081527Light Diagnostics HSV 1/2 Typing Dfa KitMillipore Corporation · 2009
  • K023892Millex VV, GV, and HV Syringe Filter UnitsMillipore Corp. · 20031 recall
  • K013988Millex GP Sterilizing Filter Unit, Model SLGP 033 RMillipore Corp. · 2002
  • K963717Millex - MP Filter Unit (SLMPO25SS/SLMPL25SS)Millipore Corp. · 1997
  • K941326Ultrafree-CLMillipore Corp. · 1994
  • K934069Millex, Dualex (Plus, Ultra)Millipore Corp. · 1994
  • K924347Waters (TM) 996 PdaMillipore Corp. · 1992

All 31 as Millipore Corp. →All 2 as Millipore Corporation →

What has been recalled?

1 recall linked to its devices; the latest:

  • K023892Millipore Millex Syringe Filter Unit, 33 mm Durapore PVDF 0.22um, Sterile, 50 Filters…Nov 25, 2009