510(k) Report

FDA applicant

Milex Products, Inc.

Chicago, IL8 decisions1976–200016 recalls

FDA records 8 decisions for Milex Products, Inc. (Chicago, IL) from 1976 to 2000: 8 510(k) clearances. Most are in product codes HHW (Pessary, Vaginal) and HHK (Curette, Suction, Endometrial (And Accessories)). 16 recalls are linked to its devices.

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

FIG. A — Illustration, obstetrics and gynecology panel, where it files most

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

FDA decisions per year

No FDA decision for Milex Products, Inc. since 2007.

Recalls per year

1in 2022

2013: 92014: 22015: 22017: 12021: 12022: 1
2007high 9 (2013) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Milex Products, Inc. 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?

  • HHWPessary, Vaginal2decisions
  • HHKCurette, Suction, Endometrial (And Accessories)2decisions
  • KNAInstrument, Manual, Specialized Obstetric-Gynecologic1decision
  • HHTSpatula, Cervical, Cytological1decision
  • GDFGuide, Needle, Surgical1decision
  • HIRPerineometer1decision

Who builds on its devices?

Later devices cite its devices 4 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.

  • K861385Milex Bartholin Gland CatheterMilex Products, Inc. · 19861cites it
  • K904026Inflat-O-BallMilex Products, Inc. · 19901cites it
  • K900903Kopans Hookwire Lesion Localization NeedleMilex Products, Inc. · 19901cites it
  • K760264Curette, Proposed Tis-U-Trap, MetalMilex Products, Inc. · 19761cites it

What has FDA decided for it lately?

  • K001545Pipet CuretMilex Products, Inc. · 2000
  • K904774Inglat-O-BallMilex Products, Inc. · 199015 recalls
  • K904026Inflat-O-BallMilex Products, Inc. · 199013 recalls
  • K900903Kopans Hookwire Lesion Localization NeedleMilex Products, Inc. · 1990
  • K882628Endo C BrushMilex Products, Inc. · 1988
  • K862410Milex Kegel Perineal ExerciserMilex Products, Inc. · 1986
  • K861385Milex Bartholin Gland CatheterMilex Products, Inc. · 1986
  • K760264Curette, Proposed Tis-U-Trap, MetalMilex Products, Inc. · 1976

All 8 as Milex Products, Inc. →

What has been recalled?

16 recalls linked to its devices; the latest:

  • K904774COOPER SURGICAL Milex PESSARY, RING MILEX INCONT FLEXIBLE SZ6 1 3/4" Catalog # MXPCON06May 25, 2022Class II
  • K904774Milex Gellhorn Flexible under the following labels: 1) Gellhorn Flexible w/Short Stem…Jan 21, 2021Class II
  • K904026CooperSurgical lnflatoball Latex Rubber Pessary sold as an individual unit and also part…Apr 10, 2017Class II
  • K904774MILEX PESSARY KIT; Model Numbers: MXPES00; MXKPES00; MXKPREG03; MXKPGSK07 Product Usage…Sep 14, 2015Class III
  • K904026CooperSurgical PESSARY KIT-CUBE#2, 1-3/8 in , 35 mm Part Number: MXKPEC02Feb 9, 2015Class II
  • K904026CooperSurgical MILEX PESSARY KITS-Ring w/Support Folding Pessary- #1 Model: MXKPRS01…Sep 30, 2014Class III