510(k) Report

510(k) · Cleared

Cleared

Esophageal Stethoscope W/Thermocouple Type T

K864043510(k) TraditionalCleared Dec 15, 198660-day reviewClass II21 CFR 868.1920

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Respiratory Support Products, Inc. · BZT Stethoscope, Esophageal, With Electrical Conductors

Cleared on Dec 15, 1986 after a 60-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.

Decided
Dec 15, 1986
Review
60 days
Class
Class II
Product code
BZT
Recalls
None
Predicates
0

2 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2007: 1 descendant cleared2011: 1 descendant cleared1990200020102020
  1. This deviceK864043 Esophageal Stethoscope W/Thermocouple Type TRespiratory Support Products, Inc. · 1986
  2. Descendant · cites it directly · 1 of its ownK072621 Esophageal/Rectal Temperature Probe and Esophageal Stethoscope with…Cincinnati Sub-Zero Products, Inc. · 2007 · Recalled
  3. Descendant · 2 generations on · 0 of its ownK110956 Medivance Nasogastric Tube Temperature SensorMedivance, Inc. · 2011

Most influential descendants

Showing 2 of 2 · See all
  • K072621Esophageal/Rectal Temperature Probe and Esophageal Stethoscope with Temperature SensorCincinnati Sub-Zero Products, Inc. · 2007 · cites it directly1descendant
  • K110956Medivance Nasogastric Tube Temperature SensorMedivance, Inc. · 2011 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K864043Esophageal Stethoscope W/Thermocouple Type TRespiratory Support Products, Inc.1986—
+1K072621Esophageal/Rectal Temperature Probe and Esophageal Stethoscope with…Cincinnati Sub-Zero Products, Inc.20071
+2K110956Medivance Nasogastric Tube Temperature SensorMedivance, Inc.2011—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
201110
FIG. 1 — Lineage of K864043, 1986–2011Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K251025 Mon-a-Therm™ Esophageal Stethoscope with…score 10.6 · 1 generation · no Class I recall
  2. #2 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K072621Esophageal/Rectal Temperature Probe and Esophageal Stethoscope with Temperature SensorCincinnati Sub-Zero Products, Inc.20071

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, K072621 (Cincinnati Sub-Zero Products, Inc., 2007) has gone furthest, with 1 descendant of its own.

How does its category compare?

All BZT devices

BZT Stethoscope, Esophageal, With Electrical Conductors: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · BZT

1in 2025

2007: 12009: 12012: 12014: 12020: 12025: 1
2007high 1 (2007) · low 0 (2008)2026

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

2011: 12026 (partial year): 3
2007high 3 (2026) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · BZT

3in 2024

2008: 42009: 12011: 22013: 22014: 12015: 22017: 22018: 12019: 32021: 32022: 12024: 3
2007high 4 (2008) · low 0 (2007)2025

MAUDE reports naming product code BZT, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—00
20080—04
20091—01
20100—00
20110—12
20121—00
20130—02
20141—01
20150—02
20160—00
20170—02
20180—01
20190—03
20201—00
20210—03
20220—01
20230—00
20240—03
20251—00
20260—3—

More from Respiratory Support Products, Inc.

27 FDA decisions under this applicant name. See the company

  • K983862Cloud 1 Humidification SystemRespiratory Support Products, Inc. · 1999
  • K921190Adap-Temp Temperature Sensor AdapterRespiratory Support Products, Inc. · 1993
  • K920469Myocardinal Temperature Sensor with Type 400 SerieRespiratory Support Products, Inc. · 1992
  • K921510Gas Sampling Kit ModificationRespiratory Support Products, Inc. · 1992
  • K913082BI-Temp Temperature Monitor,Model TM-300DRespiratory Support Products, Inc. · 1991

Recent decisions in BZT

The BZT category page

  • K251025Mon-a-Therm™ Esophageal Stethoscope with Temperature Sensor 400TM (90041, 90042, 90043, 90049)Covidien, LLC · 2025
  • K193027Esophageal Stethoscope 9 French, Esophageal Stethoscope 12 French, Esophageal Stethoscope 18 French…Deroyal Industries, Inc. · 2020
  • K140134Esophageal Stethoscope with Temperature Sensor (Non-Sterile),Esophageal Stethoscope Temperature with…Starboard Medical, LLC · 2014
  • K111050Esophageal / Rectal Temperature Probe, 9FR, 12FR, Esophageal Stethoscope with Temperature Sensor, 9FR, 12FR…Starboard Medical, LLC · 2012
  • K092716Esophageal StethoscopeTruer Medical, Inc. · 2009

https://510kreport.com/device/K864043 · printed Nov 4, 2026

Cite this page

510(k) Report. “K864043: Esophageal Stethoscope W/Thermocouple Type T.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K864043

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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