510(k) Report

FDA applicant

Cd Medical, Inc.

Miami Lakes, FL11 decisions1985–19945 recalls

FDA records 11 decisions for Cd Medical, Inc. (Miami Lakes, FL) from 1985 to 1994: 11 510(k) clearances. Most are in product codes FKP (System, Dialysate Delivery, Single Patient) and KOC (Accessories, Blood Circuit, Hemodialysis). 5 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, gastroenterology and urology panel, where it files most

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

FDA decisions per year

No FDA decision for Cd Medical, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Cd Medical, 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?

  • FKPSystem, Dialysate Delivery, Single Patient3decisions
  • KOCAccessories, Blood Circuit, Hemodialysis2decisions
  • FJKSet, Tubing, Blood, With And Without Anti-Regurgitation Valve1decision
  • FIFSet, Dialysis, Single Needle With Uni-Directional Pump1decision
  • GBZCatheter, Cholangiography1decision
  • KDIDialyzer, High Permeability With Or Without Sealed Dialysate System1decision

Also: FIP (1), FKQ (1).

Who builds on its devices?

Later devices cite its devices 7 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.

  • K910215Drake Willock System 1000 Dialysate Delivery SystCd Medical, Inc. · 19914cite it
  • K8732798810 Pump-Pump Single Needle DeviceCd Medical, Inc. · 19871cites it
  • K880459480 High-Flow Ultrafiltration Control DialysateCd Medical, Inc. · 19881cites it
  • K894106Drake Willock Reverse Osmosis Water Treatment SystCd Medical, Inc. · 19891cites it

What has FDA decided for it lately?

  • K925654CD Home Dialyservice Hemodialysis TrayCd Medical, Inc. · 1994
  • K910215Drake Willock System 1000 Dialysate Delivery SystCd Medical, Inc. · 19915 recalls
  • K901520Wurtz Choley Clip (TM)Cd Medical, Inc. · 1990
  • K894106Drake Willock Reverse Osmosis Water Treatment SystCd Medical, Inc. · 1989
  • K884353Ultrx (TM) 850 Artificial KidneyCd Medical, Inc. · 1988
  • K880459480 High-Flow Ultrafiltration Control DialysateCd Medical, Inc. · 1988
  • K8732798810 Pump-Pump Single Needle DeviceCd Medical, Inc. · 1987
  • K864784Seraflo (TM) Bloodlines for HemodialysisCd Medical, Inc. · 1987

All 11 as Cd Medical, Inc. →

What has been recalled?

5 recalls linked to its devices; the latest:

  • K030099Ultra-Filtration (UF) Removal Regulators (Rgltr Assy UF REM Molded Spare); a spare part…Jun 21, 2006
  • K910215System 1000 family of Hemodialysis Instruments, including the System 1000, TINA, AURORA…Feb 24, 2006
  • K013562System 1000 family of Hemodialysis Instruments, including the System 1000, TINA, AURORA…Nov 18, 2005
  • K910215Baxter System 1000 Single Patient Hemodialysis Delivery System; Model SYS1000; all…May 28, 2003
  • K910215Baxter System 1000 Single Patient Hemodialysis Delivery System; Model SYS1000; all…Mar 20, 2003