FDA product code BZG: Spirometer, Diagnostic
BZG is the FDA product code for spirometer, diagnostic. It is a Class II device, regulated under 21 CFR 868.1840 and reviewed by the Anesthesiology panel. FDA has cleared 228 510(k) submissions under BZG, 10 in the last five years, from 128 different applicants. The average 510(k) review took 165 days (median 145); 231 days on average over the last three years. FDA has posted 1 recall for BZG devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Spirometer, Diagnostic |
| Device class | Class II |
| Regulation | 21 CFR 868.1840 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for BZG
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 2 | 171 |
| 2018 | 1 | 192 |
| 2019 | 3 | 176 |
| 2020 | 5 | 174 |
| 2021 | 1 | 371 |
| 2022 | 2 | 174 |
| 2023 | 5 | 371 |
| 2024 | 2 | 197 |
| 2026 | 1 | 265 |
Compare with all 510(k) review times · Search every BZG clearance
Top BZG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Mir Medical Intl. Research Srl | 9 | 2013-10-30 |
| Sdi Diagnostics, Inc. | 8 | 2016-01-12 |
| Vitalograph (Ireland) , Ltd. | 6 | 2016-08-26 |
| Morgan Scientific, Inc. | 5 | 2022-07-15 |
| Puritan Bennett Corp. | 5 | 2002-12-18 |
123 more applicants have BZG clearances. See the full list in Caduvo.
Most recent BZG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K251777 | Mesi D.O.O. | MESI mTABLET SPIRO | 2026-03-02 | 265 |
| K241843 | Gostar Co., Ltd. | TD-7301 Spirometer (TD-7301) | 2024-11-20 | 147 |
| K231416 | Nuvoair AB | Air Next (NVD-02) | 2024-01-18 | 247 |
| K230501 | Mir Medical International Research USA | Spirobank Oxi | 2023-12-15 | 294 |
| K230178 | Ndd Medizintechnik AG | EasyOne Sky Spirometer | 2023-10-19 | 269 |
Recalls for BZG devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2024-10-11.
| Year | Recalls |
|---|---|
| 2024 | 1 |
Frequently asked questions
What is FDA product code BZG?
BZG is the FDA product code for spirometer, diagnostic. It is a Class II device, regulated under 21 CFR 868.1840 and reviewed by the Anesthesiology panel.
What device class is BZG?
Class II, regulation 21 CFR 868.1840. Typical premarket route: 510(k).
How long does a 510(k) take for product code BZG?
Across 228 cleared submissions the average was 165 days from receipt to decision (median 145).
Which companies have the most BZG clearances?
Mir Medical Intl. Research Srl (9); Sdi Diagnostics, Inc. (8); Vitalograph (Ireland) , Ltd. (6); Morgan Scientific, Inc. (5); Puritan Bennett Corp. (5).
Have BZG devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2024-10-11.
Next steps
- Run an FDA pathway report with predicate devices for product code BZG
- Run a recall and safety report across every BZG manufacturer
- Watch product code BZG 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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