FDA product code BZW: Stethoscope, Esophageal
BZW is the FDA product code for stethoscope, esophageal. It is a Class I device, regulated under 21 CFR 868.1910 and reviewed by the Anesthesiology panel. FDA has cleared 13 510(k) submissions under BZW, from 13 different applicants. The average 510(k) review took 43 days (median 38).
Classification
| Field | Value |
|---|---|
| Device name | Stethoscope, Esophageal |
| Device class | Class I |
| Regulation | 21 CFR 868.1910 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every BZW clearance
Top BZW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Mon-A-Therm, Inc. | 1 | 1988-01-29 |
| Sharn, Inc. | 1 | 1986-04-01 |
| Medical Parameters, Inc. | 1 | 1985-01-10 |
| Primrose Medical, Inc. | 1 | 1984-08-24 |
| Inmed Corp. | 1 | 1984-08-15 |
8 more applicants have BZW clearances. See the full list in Caduvo.
Most recent BZW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K874519 | Mon-A-Therm, Inc. | MODIFIED ESOPHAGEAL STETHOSCOPE/TEMPERATURE SENSOR | 1988-01-29 | 88 |
| K860558 | Sharn, Inc. | ESOPHAGEAL STETHOSCOPE | 1986-04-01 | 46 |
| K844444 | Medical Parameters, Inc. | ESOPHAGEAL STETHOSCOPE | 1985-01-10 | 55 |
| K843070 | Primrose Medical, Inc. | ESOPHAGEAL STETHOSCOPES | 1984-08-24 | 18 |
| K841574 | Axiom Medical, Inc. | QUAZAR ESOPHAGEAL STETHOSCOPE | 1984-08-15 | 120 |
Recalls for BZW devices
openFDA lists no recalls for product code BZW.
Frequently asked questions
What is FDA product code BZW?
BZW is the FDA product code for stethoscope, esophageal. It is a Class I device, regulated under 21 CFR 868.1910 and reviewed by the Anesthesiology panel.
What device class is BZW?
Class I, regulation 21 CFR 868.1910. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code BZW?
Across 13 cleared submissions the average was 43 days from receipt to decision (median 38).
Which companies have the most BZW clearances?
Mon-A-Therm, Inc. (1); Sharn, Inc. (1); Medical Parameters, Inc. (1); Primrose Medical, Inc. (1); Inmed Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code BZW
- Run a recall and safety report across every BZW manufacturer
- Watch product code BZW 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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