510(k) · Cleared
ClearedDebusk Temp. Syst. Esophageal Stethoscope
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 Jul 13, 1993 after a 239-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 8 later devices descend from it.
- Decided
- Jul 13, 1993
- Review
- 239 days
- Class
- Class II
- Product code
- BZT
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 2 citing it directly.
- This deviceK925789 Debusk Temp. Syst. Esophageal StethoscopeDeroyal Industries, Inc. · 1993
- Descendant · cites it directly · 6 of its ownK051873 Disposable Temperature, Skin and Esophageal ProbesGE Healthcare · 2005 · Recalled
- Descendant · 2 generations on · 5 of its ownK121999 General Purpose Temperature Probe, Skin Temperature ProbeDraeger Medical GmbH · 2013
- Descendant · 3 generations on · 2 of its ownK181967 Disposable Temperature ProbeShenzhen Launch Electrical Co., Ltd. · 2018
- Descendant · 4 generations on · 1 of its ownK193338 Med-link Reusable Temperature Probes, Med-link Disposable…Shenzhen Med-Link Electronics Tech Co., Ltd. · 2020
- Descendant · 3 generations on · 1 of its ownK182755 Disposable Temperature ProbeShenzhen Caremed Medical Technology Co., Ltd. · 2018
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K051873Disposable Temperature, Skin and Esophageal ProbesGE Healthcare · 2005 · cites it directly6descendants
- K121999General Purpose Temperature Probe, Skin Temperature ProbeDraeger Medical GmbH · 2013 · 2 generations on5descendants
- K181967Disposable Temperature ProbeShenzhen Launch Electrical Co., Ltd. · 2018 · 3 generations on2descendants
- K193338Med-link Reusable Temperature Probes, Med-link Disposable Temperature ProbesShenzhen Med-Link Electronics Tech Co., Ltd. · 2020 · 4 generations on1descendant
- K182755Disposable Temperature ProbeShenzhen Caremed Medical Technology Co., Ltd. · 2018 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K925789 | Debusk Temp. Syst. Esophageal Stethoscope | Deroyal Industries, Inc. | 1993 | — |
| +1 | K051873 | Disposable Temperature, Skin and Esophageal Probes | GE Healthcare | 2005 | 1 |
| +2 | K121999 | General Purpose Temperature Probe, Skin Temperature Probe | Draeger Medical GmbH | 2013 | — |
| +3 | K181967 | Disposable Temperature Probe | Shenzhen Launch Electrical Co., Ltd. | 2018 | — |
| +4 | K193338 | Med-link Reusable Temperature Probes, Med-link Disposable Temperature Probes | Shenzhen Med-Link Electronics Tech Co., Ltd. | 2020 | — |
| +3 | K182755 | Disposable Temperature Probe | Shenzhen Caremed Medical Technology Co., Ltd. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2013 | 1 | 0 |
| 2018 | 2 | 0 |
| 2020 | 3 | 0 |
| 2023 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (8)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K051873 (GE Healthcare, 2005) has gone furthest, with 6 descendants of its own.
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 | — |
https://510kreport.com/device/K925789 · printed Nov 6, 2026
Cite this page
510(k) Report. “K925789: Debusk Temp. Syst. 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/K925789
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026