# K072621: Esophageal/Rectal Temperature Probe and Esophageal Stethoscope with Temperature Sensor

- Pathway: 510(k) (Traditional)
- Applicant: Cincinnati Sub-Zero Products, Inc.
- Decided: Dec 13, 2007 after 87 days
- Product code: BZT (Stethoscope, Esophageal, With Electrical Conductors)
- Device class: 2
- Regulation: 21 CFR 868.1920
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K864044 (1986). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K864043: Esophageal Stethoscope W/Thermocouple Type T, Respiratory Support Products, Inc. (1986) Summary page 2.
- K864044: Esophageal/Rectal Temperature Probe W/Type T, Respiratory Support Products, Inc. (1986) Summary page 2.

## Most influential descendants
- K110956: Medivance Nasogastric Tube Temperature Sensor (2011), 0 descendants of its own

## Recalls of this device
- Sep 26, 2011 · Not classified · Z-0372-2012: 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 

## Indications for use
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.

Source page: https://510kreport.com/device/K072621
Methodology: https://510kreport.com/methodology