510(k) Report

FDA applicant

Tenacore Holdings, Inc.

Santa Ana, CA4 decisions2002–20080 recalls

FDA records 4 decisions for Tenacore Holdings, Inc. (Santa Ana, CA) from 2002 to 2008: 4 510(k) clearances. Most are in product codes DXC (Clamp, Vascular) and BZR (Mixer, Breathing Gases, Anesthesia Inhalation). Its devices cite 5 predicates, 0 of them its own earlier devices. No recall is 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 Tenacore Holdings, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2008

2008: 1
2007high 1 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Tenacore Holdings, 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?

  • DXCClamp, Vascular1decision
  • BZRMixer, Breathing Gases, Anesthesia Inhalation1decision
  • HGMSystem, Monitoring, Perinatal1decision
  • DQAOximeter1decision

Whose devices does it build on?

Its devices cite 5 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 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.

  • K081335Tenacore Oxygen Blender, Model TB-2000Tenacore Holdings, Inc. · 20081cites it
  • K053420Tenacore SP02 SensorsTenacore Holdings, Inc. · 20061cites it

What has FDA decided for it lately?

  • K081335Tenacore Oxygen Blender, Model TB-2000Tenacore Holdings, Inc. · 2008
  • K053420Tenacore SP02 SensorsTenacore Holdings, Inc. · 2006
  • K043075Tenacore Transducers for Fetal Ultrasonic and Tokodynamometer MonitoringTenacore Holdings, Inc. · 2005
  • K012041The Hammer Model H100Tenacore Holdings, Inc. · 2002

All 4 as Tenacore Holdings, Inc. →