510(k) Report

FDA applicant

Sorin Biomedical, Inc.

Irvine, CA15 decisions1993–19992 recalls

FDA records 15 decisions for Sorin Biomedical, Inc. (Irvine, CA) from 1993 to 1999: 15 510(k) clearances. Most are in product codes DTN (Reservoir, Blood, Cardiopulmonary Bypass) and DTM (Filter, Blood, Cardiopulmonary Bypass…). Its devices cite 4 predicates, 1 of them its own earlier devices. 2 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 Sorin Biomedical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Sorin Biomedical, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Sorin Biomedical, 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?

  • DTNReservoir, Blood, Cardiopulmonary Bypass8decisions
  • DTMFilter, Blood, Cardiopulmonary Bypass, Arterial Line3decisions
  • CACApparatus, Autotransfusion2decisions
  • DTQConsole, Heart-Lung Machine, Cardiopulmonary Bypass1decision
  • DTZOxygenator, Cardiopulmonary Bypass1decision

Whose devices does it build on?

Its devices cite 4 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 20 times; 1 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.

  • K934847Ngbcd & Ngbcdp Cardioplegia Delivery SystemsSorin Biomedical, Inc. · 19944cite it
  • K952270Dideco Adult Arterial Filters D732 Micro 20 W/20, D734 Micro 40 W/40 Micron ScreenSorin Biomedical, Inc. · 19953cite it
  • K933481Sorin Monolyth Venous ReservoirSorin Biomedical, Inc. · 19932cite it
  • K961869Dideco Newborn/Infant Arterial Filters: D735 Micro 20 and D736 Micro 40Sorin Biomedical, Inc. · 19962cite it
  • K934763Sorin Blood Cardioplegia SystemSorin Biomedical, Inc. · 19942cite it
  • K963759Dideco Compact-a and Compact-M Autotransfusion SystemsSorin Biomedical, Inc. · 19982cite it

What has FDA decided for it lately?

  • K990103Monolyth C 600 and 1200 Hollow Fiber Membrane Lung with Integrated Softshell Venous Reservoir , CVR 600 and…Sorin Biomedical, Inc. · 1999
  • K963758Code 150 Blood Component Collection Set and with Direct Draw LineSorin Biomedical, Inc. · 1998
  • K963759Dideco Compact-a and Compact-M Autotransfusion SystemsSorin Biomedical, Inc. · 1998
  • K964908VRF40 Venous Reservoir with Integral Cardiotomy FilterSorin Biomedical, Inc. · 1997
  • K964907Venomidicard Pediatric Venous Reservoir with Integralcardiotomy Filter/Midicard Pediatric Cardiotomy…Sorin Biomedical, Inc. · 1997
  • K961869Dideco Newborn/Infant Arterial Filters: D735 Micro 20 and D736 Micro 40Sorin Biomedical, Inc. · 1996
  • K952270Dideco Adult Arterial Filters D732 Micro 20 W/20, D734 Micro 40 W/40 Micron ScreenSorin Biomedical, Inc. · 1995
  • K945198Dideco Pediatric Arterial FiltersSorin Biomedical, Inc. · 1995

All 15 as Sorin Biomedical, Inc. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K934847Cardioplegia Pack BCD Vanguard Ratio 4:1 with ShuntMay 25, 2004
  • K934847Cobe Cardiovascular BCD Vanguard Cardioplegia Delivery System, 8:1 with Shunt.May 9, 2003

Other applicant names beginning “Sorin”

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

Sorin Group Italia S.R.L. 63Sorin Biomedica, Fiat, USA, Inc. 20Sorin Group Deutschland GmbH 20Sorin Group USA, Inc. 3Sorin Biomedica Cardio S.R.L. 1