510(k) · Cleared
ClearedEsophageal Stethoscope with Temperature Sensor (Non-Sterile),Esophageal Stethoscope Temperature with Attached Ear Piece
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Starboard Medical, LLC · BZT Stethoscope, Esophageal, With Electrical Conductors
Cleared on Jun 16, 2014 as substantially equivalent to K111050 (Starboard Medical, LLC, 2012) after a 150-day review. Its family tree reaches back 2 generations to 1986.
- Decided
- Jun 16, 2014
- Review
- 150 days
- Class
- Class II
- Product code
- BZT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K854212 (1986). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK854212 Acoustascope Esophageal Stethoscope W/Temp SensorRespiratory Support Products, Inc. · 1986
- 1 generation backK111050 Esophageal / Rectal Temperature Probe, 9FR, 12FR, Esophageal…Starboard Medical, LLC · 2012
- This deviceK140134 Esophageal Stethoscope with Temperature Sensor…Starboard Medical, LLC · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K854212 | Acoustascope Esophageal Stethoscope W/Temp Sensor | Respiratory Support Products, Inc. | 1986 | — |
| −1 | K111050 | Esophageal / Rectal Temperature Probe, 9FR, 12FR, Esophageal Stethoscope with… | Starboard Medical, LLC | 2012 | — |
| 0 (this device) | K140134 | Esophageal Stethoscope with Temperature Sensor (Non-Sterile),Esophageal… | Starboard Medical, LLC | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in BZT? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new BZT device
- #1 K251025 Mon-a-Therm™ Esophageal Stethoscope with…score 10.6 · 1 generation · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K111050 | Esophageal / Rectal Temperature Probe, 9FR, 12FR, Esophageal Stethoscope with…Summary page 1…CFR 868.1920 Predicate Device: The following device has been identified as predicate devices: Starboard Medical LLC. Esophageal Stethoscope with temperature sensor - K1 11050 Starboard Medical LLC. Esophageal/Rectal Temperature Probe - K1i11050 Description of device: Esophageal… | 2012 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 28 years and passes through 2 companies; a new generation was cleared every 26.3 years on median.
- None of the 3 ancestors has a recall.
How does its category compare?
All BZT devicesBZT Stethoscope, Esophageal, With Electrical Conductors: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · BZT
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · BZT
Too few BZT 510(k)s in any year since 2007 to give a median.
Recalls per year · BZT
3so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · BZT
3in 2024
MAUDE reports naming product code BZT, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 4 |
| 2009 | 1 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 1 | 2 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 1 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 3 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 3 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 3 | — |
What is it indicated for?
The Clarisonus Phus Esophageal Stethoscope with temperature sensor with attached earpiece is intendled for use when the esophageal temperature is continuously monitored along with the auscultation of the heart and lung sounds.
- The Esophiageal Stethoscope with temperature sensor is intended for use when the esophiageal temperature is continuously monitored along with the auscultation of the heart and lung sounds.
- The Esophageal/Rectal Temperature Probe is indicated for continuous monitoring of esophageal, rectal, and nasopharyngeal temtperatutres.
The products are intended for use in surgical and critical care patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140134 · printed Nov 5, 2026
Cite this page
510(k) Report. “K140134: Esophageal Stethoscope with Temperature Sensor (Non-Sterile),Esophageal Stethoscope Temperature with Attached Ear Piece.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K140134
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026