FDA product code BZM: Calculator, Pulmonary Function Interpretor (Diagnostic)
BZM is the FDA product code for calculator, pulmonary function interpretor (diagnostic). It is a Class II device, regulated under 21 CFR 868.1900 and reviewed by the Anesthesiology panel. FDA has cleared 26 510(k) submissions under BZM, from 16 different applicants. The average 510(k) review took 141 days (median 138).
Classification
| Field | Value |
|---|---|
| Device name | Calculator, Pulmonary Function Interpretor (Diagnostic) |
| Device class | Class II |
| Regulation | 21 CFR 868.1900 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every BZM clearance
Top BZM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Medical Graphics Corp. | 7 | 1996-07-01 |
| Karmelsonix | 3 | 2011-03-04 |
| Cdx Corp. | 2 | 1985-09-26 |
| Cybermedic, Inc. | 2 | 1984-08-17 |
| Stethographics, Inc. | 1 | 2002-04-23 |
11 more applicants have BZM clearances. See the full list in Caduvo.
Most recent BZM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K102229 | Karmelsonix | PULMOTRACK 2020 SYSTEM | 2011-03-04 | 207 |
| K090863 | Karmelsonix | PERSONAL WHEEZOMETER | 2009-09-21 | 175 |
| K071955 | Karmelsonix | WIM-PC, MODEL 1010 | 2007-11-01 | 108 |
| K012387 | Stethographics, Inc. | STG MULTICHANNEL LUNG SOUND ANALYSIS SYSTEM | 2002-04-23 | 270 |
| K980878 | Karmel Medical Acoustic Technologies , Ltd. | PULMOTRACK,MODEL 1010 | 1998-12-28 | 294 |
Recalls for BZM devices
openFDA lists no recalls for product code BZM.
Frequently asked questions
What is FDA product code BZM?
BZM is the FDA product code for calculator, pulmonary function interpretor (diagnostic). It is a Class II device, regulated under 21 CFR 868.1900 and reviewed by the Anesthesiology panel.
What device class is BZM?
Class II, regulation 21 CFR 868.1900. Typical premarket route: 510(k).
How long does a 510(k) take for product code BZM?
Across 26 cleared submissions the average was 141 days from receipt to decision (median 138).
Which companies have the most BZM clearances?
Medical Graphics Corp. (7); Karmelsonix (3); Cdx Corp. (2); Cybermedic, Inc. (2); Stethographics, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code BZM
- Run a recall and safety report across every BZM manufacturer
- Watch product code BZM 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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