FDA product code BZS: Stethoscope Head
BZS is the FDA product code for stethoscope head. It is a Class I device, regulated under 21 CFR 868.1930 and reviewed by the Anesthesiology panel. FDA has cleared 3 510(k) submissions under BZS, from 3 different applicants. The average 510(k) review took 113 days (median 74).
Classification
| Field | Value |
|---|---|
| Device name | Stethoscope Head |
| Device class | Class I |
| Regulation | 21 CFR 868.1930 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every BZS clearance
Top BZS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Modern Medical Devices, Inc. | 1 | 1994-07-11 |
| Nova Diversified Concepts | 1 | 1993-03-26 |
| Warner-Lambert Co. | 1 | 1980-05-14 |
Most recent BZS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K935146 | Modern Medical Devices, Inc. | DISPOSABLE STETHOSCOPE HEAD COVER | 1994-07-11 | 256 |
| K930118 | Nova Diversified Concepts | STETSKINS | 1993-03-26 | 74 |
| K801050 | Warner-Lambert Co. | SUPRA SCOPE | 1980-05-14 | 9 |
Recalls for BZS devices
openFDA lists no recalls for product code BZS.
Frequently asked questions
What is FDA product code BZS?
BZS is the FDA product code for stethoscope head. It is a Class I device, regulated under 21 CFR 868.1930 and reviewed by the Anesthesiology panel.
What device class is BZS?
Class I, regulation 21 CFR 868.1930. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code BZS?
Across 3 cleared submissions the average was 113 days from receipt to decision (median 74).
Which companies have the most BZS clearances?
Modern Medical Devices, Inc. (1); Nova Diversified Concepts (1); Warner-Lambert Co. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code BZS
- Run a recall and safety report across every BZS manufacturer
- Watch product code BZS 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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