510(k) Report

FDA applicant

Cobe Laboratories, Inc.

Mchenry, IL77 decisions1976–199347 recalls

FDA records 77 decisions for Cobe Laboratories, Inc. (Mchenry, IL) from 1976 to 1993: 77 510(k) clearances. Most are in product codes DTZ (Oxygenator, Cardiopulmonary Bypass) and FJI (Dialyzer, Capillary, Hollow Fiber). 47 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, cardiovascular panel, where it files most

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

FDA decisions per year

No FDA decision for Cobe Laboratories, Inc. since 2007.

Recalls per year

7in 2018

2009: 162010: 222013: 12016: 12018: 7
2007high 22 (2010) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Cobe Laboratories, 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?

  • DTZOxygenator, Cardiopulmonary Bypass6decisions
  • FJIDialyzer, Capillary, Hollow Fiber6decisions
  • FKPSystem, Dialysate Delivery, Single Patient4decisions
  • FJGDialyzer, Parallel Flow4decisions
  • DTRHeat-Exchanger, Cardiopulmonary Bypass3decisions
  • DTQConsole, Heart-Lung Machine, Cardiopulmonary Bypass3decisions

Also: DTN (3), KDI (2), JOD (2), CAC (2), DSY (2), KRL (2).

Who builds on its devices?

Later devices cite its devices 16 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.

  • K771692Tubing SetsCobe Laboratories, Inc. · 19773cite it
  • K900105Cobe Spectra Blood Component Separator TherapeuticCobe Laboratories, Inc. · 19913cite it
  • K864831Cobe Centrysystem 145E,160E,175E,190E DialyzersCobe Laboratories, Inc. · 19872cite it
  • K881330Cobe Heart/Lung Perfusion and Cardioplegia PackCobe Laboratories, Inc. · 19882cite it
  • K823338Cobe Hemoconcentrator 1.3Cobe Laboratories, Inc. · 19831cites it
  • K760624Small Vessel CannulaCobe Laboratories, Inc. · 19761cites it

What has FDA decided for it lately?

  • K923272Cobe CMS-HF Hollow Fiber Membrane OxygenatorCobe Laboratories, Inc. · 1993
  • K900105Cobe Spectra Blood Component Separator TherapeuticCobe Laboratories, Inc. · 1991
  • K905793Cobe Centry 2 Bicart Option KitCobe Laboratories, Inc. · 1991
  • K905388Cobe Centrysystem 3 Bicart Option KitCobe Laboratories, Inc. · 1991
  • K904336New Cobe Saturation/Hematocrit MonitorCobe Laboratories, Inc. · 1990
  • K902437Cobe Cardiotomy Reservoir with or Without FilterCobe Laboratories, Inc. · 1990
  • K902631Cobe Icu Conversion KitCobe Laboratories, Inc. · 1990
  • K904566New Cobe Centrysystem (TM) 100 HG DialyzerCobe Laboratories, Inc. · 1990

All 77 as Cobe Laboratories, Inc. →

What has been recalled?

47 recalls linked to its devices; the latest:

  • K881330Perfusion Pack, Rx only, Sterile EONov 9, 2018Class II
  • K810637(1) Argon Medical Devices Double Female LL Adapter, Special Adapter to Convert a Male…Oct 16, 2018Class II
  • K810637Argon Medical Devices Double Male LL Adapter, REF 040184800A, bulk, non-sterile. The…Oct 16, 2018Class II
  • K810637Argon Medical Devices AHD Luer Lock Cap, REF 501303, Sterile, Rx. The firm name on the…Oct 16, 2018Class II
  • K780271(1) Argon Medical Devices Stopcocks, Clear 4-Way Stopcock w/Male Luer Lock, REF…Oct 16, 2018Class II
  • K810637Argon Medical Devices TRI-JECT, 3 Way IV Administration Organizer without Stopcock, REF…Oct 16, 2018Class II

Other applicant names beginning “Cobe”

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

Cobe Cardiovascular, Inc. 43Cobe Renal Care, Inc. 14