Product code BZG: 510(k) clearances and predicates
Product code BZG covers MESI mTABLET SPIRO. FDA lists 228 clearances under this code in the 510(k) index. This page summarizes recent clearance volume and names recent clearances by K number so you can pick predicates faster.
Clearance volume
228 clearances on file under product code BZG. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 2 |
| 2023 | 5 |
| 2024 | 2 |
| 2025 | 0 |
| 2026 so far | 1 |
Recent clearances
Newest BZG clearances in the FDA index, with applicant and decision date:
- K251777, MESI mTABLET SPIRO, applicant Mesi D.O.O., decided 2026-03-02. FDA record
- K241843, TD-7301 Spirometer (TD-7301), applicant Gostar Co., Ltd., decided 2024-11-20. FDA record
- K231416, Air Next (NVD-02), applicant Nuvoair AB, decided 2024-01-18. FDA record
- K230501, Spirobank Oxi, applicant Mir Medical International Research USA, decided 2023-12-15. FDA record
- K230178, EasyOne Sky Spirometer, applicant Ndd Medizintechnik AG, decided 2023-10-19. FDA record
- K222525, Alveoair Digital Spirometer, applicant Roundworks Technologies Private Limited, decided 2023-08-28. FDA record
- K222443, Air Smart Extra Spirometer, applicant Feellife Health, Inc., decided 2023-08-09. FDA record
- K213754, SpiroHome Personal, SpiroHome Clinic, applicant Inofab Saglik Teknolojileri A.S, decided 2023-06-12. FDA record
What this means for a regulatory watcher
Volume tells you how deep the predicate pool is. A code with steady yearly counts gives you many candidate predicates, which helps when one predicate has a recall or design gap. A code with a sharp recent rise means reviewers are seeing more of this device type, so substantial equivalence arguments need to track the newest cleared devices, not five year old ones. Related device names in recent clearances include TD-7301 Spirometer (TD-7301), Air Next (NVD-02). Watch new BZG clearances as they post: each one is a possible predicate for your submission and a possible competitor worth reading.
FAQ
What is FDA product code BZG?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent BZG clearances include MESI mTABLET SPIRO.
How many 510(k) clearances use product code BZG?
228 at the time this page was generated, from openFDA records.
How do I find a predicate device under BZG?
Start with the recent K numbers listed above, then run the free predicate search to check substantial equivalence text and review history.
How do I track new BZG clearances?
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Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.