FDA product code BZH: Meter, Peak Flow, Spirometry
BZH is the FDA product code for meter, peak flow, spirometry. It is a Class II device, regulated under 21 CFR 868.1860 and reviewed by the Anesthesiology panel. FDA has cleared 81 510(k) submissions under BZH, 6 in the last five years, from 55 different applicants. The average 510(k) review took 205 days (median 184); 312 days on average over the last three years.
Classification
| Field | Value |
|---|---|
| Device name | Meter, Peak Flow, Spirometry |
| Device class | Class II |
| Regulation | 21 CFR 868.1860 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for BZH
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 249 |
| 2018 | 3 | 132 |
| 2019 | 1 | 212 |
| 2020 | 2 | 120 |
| 2021 | 1 | 210 |
| 2023 | 1 | 459 |
| 2024 | 3 | 354 |
| 2026 | 2 | 269 |
Compare with all 510(k) review times · Search every BZH clearance
Top BZH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Monaghan Medical Corp. | 10 | 2013-04-17 |
| Clement Clarke Intl., Ltd. | 4 | 2006-01-31 |
| Enact Health Management Systems | 3 | 1998-10-29 |
| Healthscan Products, Inc. | 3 | 1996-10-25 |
| Health Products, Inc. | 3 | 1992-08-13 |
50 more applicants have BZH clearances. See the full list in Caduvo.
Most recent BZH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K253180 | Microlife Corporation | Microlife Digital Peak Flow Meter, Model PF200B (PF200B) | 2026-06-23 | 270 |
| K252802 | Shenzhen Bi-Rich Medical Devices Co., Ltd. | Peak Flow Meter (PF-10(BR-PEF231)) | 2026-05-29 | 268 |
| K241338 | Chongqing Moffy Innovation Technology Co., Ltd. | Peak Flow Meter | 2024-12-31 | 232 |
| K232588 | Knox Medical Diagnostics | Aluna 2 | 2024-11-25 | 458 |
| K230423 | Taian Dalu Medical Instrument Co., Ltd. | Electronic Peak Flow Meter | 2024-02-23 | 371 |
Recalls for BZH devices
openFDA lists no recalls for product code BZH.
Frequently asked questions
What is FDA product code BZH?
BZH is the FDA product code for meter, peak flow, spirometry. It is a Class II device, regulated under 21 CFR 868.1860 and reviewed by the Anesthesiology panel.
What device class is BZH?
Class II, regulation 21 CFR 868.1860. Typical premarket route: 510(k).
How long does a 510(k) take for product code BZH?
Across 81 cleared submissions the average was 205 days from receipt to decision (median 184).
Which companies have the most BZH clearances?
Monaghan Medical Corp. (10); Clement Clarke Intl., Ltd. (4); Enact Health Management Systems (3); Healthscan Products, Inc. (3); Health Products, Inc. (3).
Next steps
- Run an FDA pathway report with predicate devices for product code BZH
- Run a recall and safety report across every BZH manufacturer
- Watch product code BZH 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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