510(k) Report

FDA product code · Anesthesiology

Stethoscope, Esophageal, With Electrical Conductors

BZTClass II21 CFR 868.1920510(k) required46 decisions since 19794 recalls

46 FDA decisions since 1979. 510(k) reviews decided 2021–2025 took a median of 271 days (half between 271 and 271). 4 recalls name this code, 0 of them Class I. The most-cited predicate is K925789, named by 2 later devices.

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

FIG. A — Illustration, anesthesiology panel

Twenty years of BZT at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

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—
FIG. 1 — BZT by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in BZT? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report