510(k) Report

FDA applicant

Origen Biomedical, Inc.

Austin, TX4 decisions2001–201216 recalls

FDA records 4 decisions for Origen Biomedical, Inc. (Austin, TX) from 2001 to 2012: 4 510(k) clearances. Most are in product codes LPZ (Container, Frozen Donor Tissue Storage) and DQO (Catheter, Intravascular, Diagnostic). Its devices cite 1 predicate, 0 of them its own earlier devices. 16 recalls are linked to its devices, 9 Class I.

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 Origen Biomedical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2012

2012: 1
2007high 1 (2012) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

7in 2018

2015: 2, 2 Class I2017: 7, 7 Class I2018: 7
2007high 7 (2017) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Origen 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?

  • LPZContainer, Frozen Donor Tissue Storage1decision
  • DQOCatheter, Intravascular, Diagnostic1decision
  • DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass1decision
  • DWCController, Temperature, Cardiopulmonary Bypass1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 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.

  • K003288Origen Dual Lumen CatheterOrigen Biomedical, Inc. · 20013cite it

What has FDA decided for it lately?

  • K113869Origen Reinforced Dual Lumen CatheterOrigen Biomedical, Inc. · 20129 Class I recalls
  • K021702Cryobag, Model CBOrigen Biomedical, Inc. · 2002
  • K003288Origen Dual Lumen CatheterOrigen Biomedical, Inc. · 2001
  • K003145Origen Bladder HolderOrigen Biomedical, Inc. · 2001

All 4 as Origen Biomedical, Inc. →

What has been recalled?

16 recalls linked to its devices; the latest:

  • K113869Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO; and ECMO Reinforced Dual…Aug 21, 2018Class II
  • K113869Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO; and ECMO Reinforced Dual…Aug 21, 2018Class II
  • K113869ECMO Reinforced Dual Lumen Cannula, 28Fr., REF: VV28F, Sterile EO Indications: The…Aug 21, 2018Class II
  • K113869Reinforced Dual Lumen Cannula, 16Fr., REF: VV16F, Sterile EO Indications: The OriGen…Aug 21, 2018Class II
  • K113869Reinforced Dual Lumen Cannula, 19Fr., REF: VV19F, Sterile EO Indications: The OriGen…Aug 21, 2018Class II
  • K113869Reinforced Dual Lumen Cannula, 23Fr., REF: VV23F, Sterile EO Indications: The OriGen…Aug 21, 2018Class II