510(k) Report

FDA applicant

C.G.H. Medical, Inc.

Lakewood, CO11 decisions1991–19950 recalls

FDA records 11 decisions for C.G.H. Medical, Inc. (Lakewood, CO) from 1991 to 1995: 11 510(k) clearances. Most are in product codes KDI (Dialyzer, High Permeability With Or Without…) and CAN (Regulator, Pressure, Gas Cylinder). No recall is linked to its devices.

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

FIG. A — Illustration, gastroenterology and urology panel, where it files most

How often FDA has decided C.G.H. Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for C.G.H. Medical, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like C.G.H. Medical, Inc.’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?

  • KDIDialyzer, High Permeability With Or Without Sealed Dialysate System5decisions
  • CANRegulator, Pressure, Gas Cylinder2decisions
  • KPODialysate Concentrate For Hemodialysis (Liquid Or Powder)1decision
  • KOCAccessories, Blood Circuit, Hemodialysis1decision
  • FJGDialyzer, Parallel Flow1decision
  • FJIDialyzer, Capillary, Hollow Fiber1decision

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.

  • K940601Gambro Bicart 720GC.G.H. Medical, Inc. · 19943cite it
  • K933818Gambro Polyflux II Hemodialyzerialyzer HemodiafilterC.G.H. Medical, Inc. · 19951cites it
  • K924437Hemospal Kit B22 / Multiflow 60 KitC.G.H. Medical, Inc. · 19941cites it

What has FDA decided for it lately?

  • K941708Cobe Centrysystem CS500 DialyzerC.G.H. Medical, Inc. · 1995
  • K933818Gambro Polyflux II Hemodialyzerialyzer HemodiafilterC.G.H. Medical, Inc. · 1995
  • K925522Centrysystem 3 with Charts/BP OptionC.G.H. Medical, Inc. · 1994
  • K920757Filtral HemodialyzersC.G.H. Medical, Inc. · 1994
  • K931720Lundia Alpha 700 HemodialyzerC.G.H. Medical, Inc. · 1994
  • K924437Hemospal Kit B22 / Multiflow 60 KitC.G.H. Medical, Inc. · 1994
  • K940601Gambro Bicart 720GC.G.H. Medical, Inc. · 1994
  • K915154Gambro Engstrom Y Filter PKG. Alone W/ Var.ModelsC.G.H. Medical, Inc. · 1992

All 11 as C.G.H. Medical, Inc. →