510(k) · Cleared
ClearedEsophageal Stethoscope 9 French, Esophageal Stethoscope 12 French, Esophageal Stethoscope 18 French, Esophageal Stethoscope, 24 French
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Deroyal Industries, Inc. · BZT Stethoscope, Esophageal, With Electrical Conductors
Cleared on Apr 2, 2020 as substantially equivalent to K925789 (Deroyal Industries, Inc., 1993) after a 155-day review. Its family tree reaches back 1 generation to 1993.
- Decided
- Apr 2, 2020
- Review
- 155 days
- Class
- Class II
- Product code
- BZT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K925789 (1993). No later device cites it as a predicate yet.
- Root · 1 generation backK925789 Debusk Temp. Syst. Esophageal StethoscopeDeroyal Industries, Inc. · 1993
- This deviceK193027 Esophageal Stethoscope 9 French, Esophageal Stethoscope 12 French…Deroyal Industries, Inc. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K925789 | Debusk Temp. Syst. Esophageal Stethoscope | Deroyal Industries, Inc. | 1993 | — |
| 0 (this device) | K193027 | Esophageal Stethoscope 9 French, Esophageal Stethoscope 12 French, Esophageal… | Deroyal Industries, Inc. | 2020 | — |
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
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 |
|---|---|---|---|
| * | K925789 | Debusk Temp. Syst. Esophageal StethoscopeSummary page 4…Anesthesiology Predicate Devices: DeBusk Temperature Systems Esophageal Stethoscope [K925789] Page 5-2… | 1993 |
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?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K925789.
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. 2020, 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 DeRoyal Esophageal Stethoscope with Temperature Sensor is to be used for routine monitoring of core body temperature, as well as heart and respiratory sounds in an anesthetized patient by inserting the stethoscope tube into the esophagus.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K193027 · printed Nov 6, 2026
Cite this page
510(k) Report. “K193027: Esophageal Stethoscope 9 French, Esophageal Stethoscope 12 French, Esophageal Stethoscope 18 French, Esophageal Stethoscope, 24 French.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K193027
Report an extraction error
Are you the manufacturer?
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