Cleared Traditional

ESOPHAGEAL / RECTAL TEMPERATURE PROBE, 9FR, 12FR, ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR, 9FR, 12FR, 18FR, 24FR (K111050) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K111050 · Starboard Medical, LLC · Anesthesiology device
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Apr 2012
Decision
363d
Days
Class 2
Risk

K111050 is an FDA 510(k) clearance for the ESOPHAGEAL / RECTAL TEMPERATURE PROBE, 9FR, 12FR, ESOPHAGEAL STETHOSCOPE WITH.... Classified as Stethoscope, Esophageal, With Electrical Conductors (product code BZT), Class II - Special Controls.

Submitted by Starboard Medical, LLC (Yorba Linda, US). The FDA issued a Cleared decision on April 12, 2012 after a review of 363 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1920 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Starboard Medical, LLC devices

Submission Details

510(k) Number K111050 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 2011
Decision Date April 12, 2012
Days to Decision 363 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
223d slower than avg
Panel avg: 140d · This submission: 363d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code BZT Stethoscope, Esophageal, With Electrical Conductors
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1920
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Peers - BZT Stethoscope, Esophageal, With Electrical Conductors

Devices cleared under the same product code (BZT) and FDA review panel - the closest regulatory comparables to K111050.
Mon-a-Therm™ Esophageal Stethoscope with Temperature Sensor 400TM (90041, 90042, 90043, 90049)
K251025 · Covidien, LLC · Dec 2025
Esophageal Stethoscope 9 French, Esophageal Stethoscope 12 French, Esophageal Stethoscope 18 French, Esophageal Stethoscope, 24 French
K193027 · Deroyal Industries, Inc. · Apr 2020
DEBUSK TEMPERATURE SYSTEMS PREMIER AND SIGNATURE SERIES MULTI-PURPOSE ESOPHAGEAL STETHOSCOPE
K940169 · Deroyal Industries, Inc. · Jul 1994
DEBUSK TEMP. SYST. ESOPHAGEAL STETHOSCOPE
K925789 · Deroyal Industries, Inc. · Jul 1993
ARGYLE ACC-U-THERM W/TEMPERATURE PROBE
K812976 · Sherwood Medical Co. · Dec 1981
HI-LO TEMP ESOPHAGEAL STETHOSCOPE
K811862 · Mallinckrodt Critical Care · Jul 1981