510(k) Report

FDA applicant

Starboard Medical, LLC

Yorba Linda, CA3 decisions2011–20140 recalls

FDA records 3 decisions for Starboard Medical, LLC (Yorba Linda, CA) from 2011 to 2014: 3 510(k) clearances. Most are in product codes BZT (Stethoscope, Esophageal, With Electrical…) and FLL (Continuous Measurement Thermometer). Its devices cite 5 predicates, 1 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, anesthesiology panel, where it files most

How often FDA has decided Starboard Medical, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2014

2011: 12012: 12014: 1
2011high 1 (2011) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2011.

FIG. 1 — Starboard Medical, LLC by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • BZTStethoscope, Esophageal, With Electrical Conductors2decisions
  • FLLContinuous Measurement Thermometer1decision

Whose devices does it build on?

Its devices cite 5 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K111050Esophageal / Rectal Temperature Probe, 9FR, 12FR, Esophageal Stethoscope with Temperature Sensor, 9FR, 12FR…Starboard Medical, LLC · 20121cites it

What has FDA decided for it lately?

  • K140134Esophageal Stethoscope with Temperature Sensor (Non-Sterile),Esophageal Stethoscope Temperature with…Starboard Medical, LLC · 2014
  • K111050Esophageal / Rectal Temperature Probe, 9FR, 12FR, Esophageal Stethoscope with Temperature Sensor, 9FR, 12FR…Starboard Medical, LLC · 2012
  • K111282Disposable Temperature Probes / Sensors and Interconnect Instrument CablesStarboard Medical, LLC · 2011

All 3 as Starboard Medical, LLC →