FDA product code BZT: Stethoscope, Esophageal, With Electrical Conductors
BZT is the FDA product code for stethoscope, esophageal, with electrical conductors. It is a Class II device, regulated under 21 CFR 868.1920 and reviewed by the Anesthesiology panel. FDA has cleared 46 510(k) submissions under BZT, 1 in the last five years, from 34 different applicants. The average 510(k) review took 102 days (median 62); 271 days on average over the last three years. FDA has posted 4 recalls for BZT devices, 3 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Stethoscope, Esophageal, With Electrical Conductors |
| Device class | Class II |
| Regulation | 21 CFR 868.1920 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for BZT
| Year | Clearances | Avg. review days |
|---|---|---|
| 2020 | 1 | 155 |
| 2025 | 1 | 271 |
Compare with all 510(k) review times · Search every BZT clearance
Top BZT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Sheridan Catheter Corp. | 4 | 1988-06-16 |
| Deroyal Industries, Inc. | 3 | 2020-04-02 |
| Starboard Medical, LLC | 2 | 2014-06-16 |
| Yellow Springs Instrument Co., Inc. | 2 | 1992-11-04 |
| Vitacomm, Inc. | 2 | 1989-01-30 |
29 more applicants have BZT clearances. See the full list in Caduvo.
Most recent BZT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K251025 | Covidien, LLC | Mon-a-Therm Esophageal Stethoscope with Temperature Sensor 400TM (90041, 90042, 90043, 90049) | 2025-12-29 | 271 |
| K193027 | Deroyal Industries, Inc. | Esophageal Stethoscope 9 French, Esophageal Stethoscope 12 French, Esophageal Stethoscope 18 French, Esophageal Stethoscope, 24 French | 2020-04-02 | 155 |
| K140134 | Starboard Medical, LLC | ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR (NON-STERILE),ESOPHAGEAL STETHOSCOPE TEMPERATURE WITH ATTACHED EAR PIECE | 2014-06-16 | 150 |
| K111050 | Starboard Medical, LLC | ESOPHAGEAL / RECTAL TEMPERATURE PROBE, 9FR, 12FR, ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR, 9FR, 12FR, 18FR, 24FR | 2012-04-12 | 363 |
| K092716 | Truer Medical, Inc. | ESOPHAGEAL STETHOSCOPE | 2009-09-17 | 14 |
Recalls for BZT devices
4 product recalls in 2 recall events; 3 initiated in the last five years and 3 still open. Most recent: 2026-04-23.
| Year | Recalls |
|---|---|
| 2026 | 3 |
Frequently asked questions
What is FDA product code BZT?
BZT is the FDA product code for stethoscope, esophageal, with electrical conductors. It is a Class II device, regulated under 21 CFR 868.1920 and reviewed by the Anesthesiology panel.
What device class is BZT?
Class II, regulation 21 CFR 868.1920. Typical premarket route: 510(k).
How long does a 510(k) take for product code BZT?
Across 46 cleared submissions the average was 102 days from receipt to decision (median 62).
Which companies have the most BZT clearances?
Sheridan Catheter Corp. (4); Deroyal Industries, Inc. (3); Starboard Medical, LLC (2); Yellow Springs Instrument Co., Inc. (2); Vitacomm, Inc. (2).
Have BZT devices been recalled?
Yes: 4 product recalls across 2 recall events; the most recent began 2026-04-23.
Next steps
- Run an FDA pathway report with predicate devices for product code BZT
- Run a recall and safety report across every BZT manufacturer
- Watch product code BZT for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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