510(k) · Cleared
Recalled · 2011Esophageal/Rectal Temperature Probe and Esophageal Stethoscope with Temperature Sensor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cincinnati Sub-Zero Products, Inc. · BZT Stethoscope, Esophageal, With Electrical Conductors
Cleared on Dec 13, 2007 as substantially equivalent to K864043 (Respiratory Support Products, Inc., 1986) and 1 other predicate after an 87-day review. Its family tree reaches back 1 generation to 1986. 1 later device descends from it. It has been recalled once.
- Decided
- Dec 13, 2007
- Review
- 87 days
- Class
- Class II
- Product code
- BZT
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 1 generation to K864044 (1986). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK864044 Esophageal/Rectal Temperature Probe W/Type TRespiratory Support Products, Inc. · 1986
- This deviceK072621 Esophageal/Rectal Temperature Probe and Esophageal Stethoscope with…Cincinnati Sub-Zero Products, Inc. · 2007
- Descendant · cites it directly · 0 of its ownK110956 Medivance Nasogastric Tube Temperature SensorMedivance, Inc. · 2011
Most influential descendants
Showing 1 of 1 · See all- K110956Medivance Nasogastric Tube Temperature SensorMedivance, Inc. · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K864044 | Esophageal/Rectal Temperature Probe W/Type T | Respiratory Support Products, Inc. | 1986 | — |
| 0 (this device) | K072621 | Esophageal/Rectal Temperature Probe and Esophageal Stethoscope with… | Cincinnati Sub-Zero Products, Inc. | 2007 | — |
| +1 | K110956 | Medivance Nasogastric Tube Temperature Sensor | Medivance, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 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 |
|---|---|---|---|
| * | K864043 | Esophageal Stethoscope W/Thermocouple Type TSummary page 2…ope With Temperature Sensor Probe - ohdevices are originally, listed under Respiratory Support Products, Inc. as referenced in 510OK umiber's: K864043 & K864044 Device Description: isposable Temperature Probes using thermistors as temperature sensors. The signal of the… | 1986 |
| * | K864044 | Esophageal/Rectal Temperature Probe W/Type TSummary page 2…emperature Sensor Probe - ohdevices are originally, listed under Respiratory Support Products, Inc. as referenced in 510OK umiber's: K864043 & K864044 Device Description: isposable Temperature Probes using thermistors as temperature sensors. The signal of the sensor… | 1986 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K110956 | Medivance Nasogastric Tube Temperature Sensor | 2011 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 26, 2011 | Not classified | Z-0372-2012 | Nonconforming Material/Component | Reports that the Rectal/ Esophageal Temperature Probes are not reading correctly. This situation causes the Blanketrol device, which the probes connect to, to shut down operation and display a 'check probe' error. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 2 ancestors has a recall.
- Of its descendants, K110956 (Medivance, Inc., 2011) has gone furthest, with 0 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. 2007, 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 CSZ esophageal/rectal temperature probe is intended for use in routine continuous monitoring of the esophageal or rectal temperature as an indicator or core body temperature. The probe is designed for placement in the esophagus or rectum.
The CSZ esophageal stethoscope with temperature sensor is intended for use when the esophageal temperature is continuously monitored along with the auscultation of the heart and lung sound as an indicator of core body temperature and cardio-pulmonary performance.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072621 · printed Nov 6, 2026
Cite this page
510(k) Report. “K072621: Esophageal/Rectal Temperature Probe and Esophageal Stethoscope with Temperature Sensor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072621
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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