510(k) · Cleared

Cleared

Esophageal / Rectal Temperature Probe, 9FR, 12FR, Esophageal Stethoscope with Temperature Sensor, 9FR, 12FR, 18FR, 24FR

K111050510(k) TraditionalCleared Apr 12, 2012363-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

Starboard Medical, LLC · BZT Stethoscope, Esophageal, With Electrical Conductors

Cleared on Apr 12, 2012 as substantially equivalent to K863646 (Respiratory Support Products, Inc., 1986) and 1 other predicate after a 363-day review. Its family tree reaches back 1 generation to 1986. 1 later device descends from it.

Decided: Apr 12, 2012
Review: 363 days
Class: Class II
Product code: BZT
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K854212 (1986). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK854212 Acoustascope Esophageal Stethoscope W/Temp SensorRespiratory Support Products, Inc. · 1986
This deviceK111050 Esophageal / Rectal Temperature Probe, 9FR, 12FR, Esophageal…Starboard Medical, LLC · 2012
Descendant · cites it directly · 0 of its ownK140134 Esophageal Stethoscope with Temperature Sensor…Starboard Medical, LLC · 2014

Most influential descendants

Showing 1 of 1 · See all

K140134Esophageal Stethoscope with Temperature Sensor (Non-Sterile),Esophageal Stethoscope…Starboard Medical, LLC · 2014 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K854212	Acoustascope Esophageal Stethoscope W/Temp Sensor	Respiratory Support Products, Inc.	1986	—
0 (this device)	K111050	Esophageal / Rectal Temperature Probe, 9FR, 12FR, Esophageal Stethoscope with…	Starboard Medical, LLC	2012	—
+1	K140134	Esophageal Stethoscope with Temperature Sensor (Non-Sterile),Esophageal…	Starboard Medical, LLC	2014	—

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
2014	1	0

FIG. 1 — Lineage of K111050, 1986–2014Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Get a 510(k) 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	Applicant	Decided	Recalls
*	K863646	Esophageal Rectal Temperature Probe Summary page 1 …gy, Reg# 21 CFR 868.1920 Predicate Device: The following devices have been identified as predicate devices: SMITHS LEVEL 1 Esophageal / Rectal temperature probe - K863646 SMITHS LEVEL 1 Esophageal Stethoscope with temperature sensor - K854212 Description of device: The Starboard Medical temp…	Respiratory Support Products, Inc.	1986	—
*	K854212	Acoustascope Esophageal Stethoscope W/Temp Sensor Summary page 1 …tified as predicate devices: SMITHS LEVEL 1 Esophageal / Rectal temperature probe - K863646 SMITHS LEVEL 1 Esophageal Stethoscope with temperature sensor - K854212 Description of device: The Starboard Medical temperature probes are intended for use in clinical situations where continuous mon…	Respiratory Support Products, Inc.	1986	—

Also cleared against K863646: 1 other device →

What descends from it? (1)

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

Number	Device	Applicant	Decided	Descendants
K140134	Esophageal Stethoscope with Temperature Sensor (Non-Sterile),Esophageal Stethoscope…	Starboard Medical, LLC	2014	0

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.
Of its descendants, K140134 (Starboard Medical, LLC, 2014) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate K863646.

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. 2012, this device’s year, is highlighted.

FDA decisions per year · BZT

1in 2025

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

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

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

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 Starboard Medical Esophageal / Rectal temperature probe is indicated for continuous patient temperature monitoring, when these placement sites are clinically recommended. The probe is designed for insertion into the esophagus, nasopharynx, or rectum.

The Starboard Medical Esophageal Stethoscope with temperature sensor is indicated for continuous monitoring of patient temperature along with auscultation of the heart and lung sounds. The probe is designed for insertion into the esophagus.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K111050 · printed Nov 6, 2026

Cite this page

510(k) Report. “K111050: Esophageal / Rectal Temperature Probe, 9FR, 12FR, Esophageal Stethoscope with Temperature Sensor, 9FR, 12FR, 18FR, 24FR.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111050

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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