510(k) Report

FDA applicant

Cobe Cardiovascular, Inc.

Arvada, CO43 decisions1992–200532 recalls

FDA records 43 decisions for Cobe Cardiovascular, Inc. (Arvada, CO) from 1992 to 2005: 43 510(k) clearances. Most are in product codes DTN (Reservoir, Blood, Cardiopulmonary Bypass) and DTZ (Oxygenator, Cardiopulmonary Bypass). Its devices cite 20 predicates, 11 of them its own earlier devices. 32 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 Cardiovascular, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

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

Recalls per year

1in 2019

2009: 22017: 172019: 1
2007high 17 (2017) · low 0 (2007)2026

Class I Class II/III not classified

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

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

See the 510(k) Report

Which product codes does it file in?

  • DTNReservoir, Blood, Cardiopulmonary Bypass9decisions
  • DTZOxygenator, Cardiopulmonary Bypass8decisions
  • CACApparatus, Autotransfusion7decisions
  • DTRHeat-Exchanger, Cardiopulmonary Bypass3decisions
  • DTMFilter, Blood, Cardiopulmonary Bypass, Arterial Line3decisions
  • DTPDefoamer, Cardiopulmonary Bypass2decisions

Also: KFM (2), DWF (2), DQO (1), DWE (1), DRT (1), JQC (1).

Whose devices does it build on?

Its devices cite 20 predicates; 11 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 36 times; 11 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.

  • K002493Dideco Micro 40 PH.I.S.I.O (Phosphorylcholine Insert Surface in Oxgenation) Newborn/Infant Arterial FilterCobe Cardiovascular, Inc. · 20005cite it
  • K011835Cobe RevolutionCobe Cardiovascular, Inc. · 20024cite it
  • K960974Cobe Century Perfusion PumpCobe Cardiovascular, Inc. · 19973cite it
  • K030462Cobe Revolution Centrifugal Blood Pump with PC, Model 050300700Cobe Cardiovascular, Inc. · 20033cite it
  • K933625Brat 2 Autologus Blood Salvage SystemCobe Cardiovascular, Inc. · 19932cite it
  • K040184Dideco Micro 40 PH.I.S.I.O. Adult Arterial FilterCobe Cardiovascular, Inc. · 20042cite it

What has FDA decided for it lately?

  • K050111Smarxt BMR 1900 Closed Venous Reservoir BagCobe Cardiovascular, Inc. · 2005
  • K042473Cobe Angel Whole Blood Separation SystemCobe Cardiovascular, Inc. · 2004
  • K040184Dideco Micro 40 PH.I.S.I.O. Adult Arterial FilterCobe Cardiovascular, Inc. · 2004
  • K033641Smarxt VVR4000I Plus Filtered Hardshell Venous Reservoir, Model 439914800Cobe Cardiovascular, Inc. · 2003
  • K030462Cobe Revolution Centrifugal Blood Pump with PC, Model 050300700Cobe Cardiovascular, Inc. · 20031 recall
  • K021830Sorin Biomedica Smarxt BCD Vanguard Surface Modified Cardioplegia SystemCobe Cardiovascular, Inc. · 2002
  • K011835Cobe RevolutionCobe Cardiovascular, Inc. · 20021 recall
  • K013480Cobe Smarxt Optimin Surface Modified Hollow Fiber Membrane OxygenatorCobe Cardiovascular, Inc. · 20012 recalls

All 43 as Cobe Cardiovascular, Inc. →

What has been recalled?

32 recalls linked to its devices; the latest:

  • K981613LivaNova SMART PERFUSION PACK INSPIRE 8S - Product Usage: The affected product is a…Jul 3, 2019Class III
  • K981613Sorin Group Smart Perfusion Pack E-Pack, REF 088511400, Rev: L, Single Use, Sterile, Rx.…Dec 19, 2017Class III
  • K981613Non-Sterile Sample, Sorin Group, Smart Perfusion Pack, Ref 627376401, 1 EA, Not for…Jun 29, 2017Class II
  • K981613SORIN GROUP, SMART PERFUSION PACK, INSPIRE 8S, REF 044036101, STERILE EO, Rx Only, 1 EAJun 29, 2017Class II
  • K981613SORIN GROUP, SMART PERFUSION PACK, SMART 3/16" PEDS PACK, REF 627263601, STERILE EO, Rx…Jun 29, 2017Class II
  • K981613SORIN GROUP, SMART PERFUSION PACK, SMART CIRCULATORY ASSIST PACK, REF 627255003, STERILE…Jun 29, 2017Class II

Other applicant names beginning “Cobe”

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

Cobe Laboratories, Inc. 77Cobe Renal Care, Inc. 14