# BZT: Stethoscope, Esophageal, With Electrical Conductors

- Device class: 2; regulation: 21 CFR 868.1920; FDA's rule: 510(k) required
- FDA decisions: 46
- 510(k) review time 2021–2025: median 271 days (middle half 271–271)
- Recalls: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 1995: 2
- 1996: 1
- 1998: 2
- 2006: 1
- 2007: 1
- 2009: 1
- 2012: 1
- 2014: 1
- 2020: 1
- 2025: 1

## Most-cited predicates
- K925789: Debusk Temp. Syst. Esophageal Stethoscope (1993), cited by 2
- K811862: HI-LO Temp Esophageal Stethoscope (1981), cited by 1
- K864043: Esophageal Stethoscope W/Thermocouple Type T (1986), cited by 1
- K072621: Esophageal/Rectal Temperature Probe and Esophageal Stethoscope with Temperature Sensor (2007), cited by 1
- K111050: Esophageal / Rectal Temperature Probe, 9FR, 12FR, Esophageal Stethoscope with Temperature Sensor, 9FR, 12FR, 18FR, 24FR (2012), cited by 1
- K982193: Esophageal Stethoscope (1998), cited by 1
- K864858: Lifesound (TM) Esophageal Stethoscope W/Thermistor (1987), cited by 1
- K854212: Acoustascope Esophageal Stethoscope W/Temp Sensor (1986), cited by 1

Source page: https://510kreport.com/product-code/BZT
Data by year (CSV): https://510kreport.com/product-code/BZT.csv