510(k) · Cleared
ClearedLifesound Esophageal Stethoscope
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Novamed, LLC · BZT Stethoscope, Esophageal, With Electrical Conductors
Cleared on Sep 5, 2006 as substantially equivalent to K864858 (Biomedical Concepts, Inc., 1987) and 1 other predicate after a 50-day review. Its family tree reaches back 1 generation to 1987.
- Decided
- Sep 5, 2006
- Review
- 50 days
- Class
- Class II
- Product code
- BZT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K864858 (1987). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK864858 Lifesound (TM) Esophageal Stethoscope W/ThermistorBiomedical Concepts, Inc. · 1987
- This deviceK062020 Lifesound Esophageal StethoscopeNovamed, LLC · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K864858 | Lifesound (TM) Esophageal Stethoscope W/Thermistor | Biomedical Concepts, Inc. | 1987 | — |
| 0 (this device) | K062020 | Lifesound Esophageal Stethoscope | Novamed, LLC | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 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? (2)
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 |
|---|---|---|---|
| * | K864858 | Lifesound (TM) Esophageal Stethoscope W/ThermistorSummary page 1…eal with electrical connectors Device: Lifesound esophageal stethoscope Predicate Devices: Biomedical Concepts (NovaMed) - K864858 Shore Medical - K982 193 IDevice Description: The NovaMed esophageal stethoscopes are long t… | 1987 |
| * | K982193 | Esophageal StethoscopeSummary page 1…Lifesound esophageal stethoscope Predicate Devices: Biomedical Concepts (NovaMed) - K864858 Shore Medical - K982 193 IDevice Description: The NovaMed esophageal stethoscopes are long tubes which at the distal end have openings in the side wall a… | 1998 |
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?
- None of the 2 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.
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?
Indicated for use as an esophageal stethoscope to listen to patient heart and breathe sounds while a patient is under anesthesia or sedation.
Optionally it may be used as a temperature sensor to monitor patient temperature.
The electrical conductors are YSI 400 or 700 series compatible.
They can be provided "clean, non-sterile" or "sterile".
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062020 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062020: Lifesound Esophageal Stethoscope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062020
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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