BZG · Class II · 21 CFR 868.1840

FDA Product Code BZG: Spirometer, Diagnostic

Leading manufacturers include Vitalograph (Ireland) , Ltd., Nuvoair AB and Morgan Scientific, Inc..

228
Total
228
Cleared
165d
Avg days
1977
Since
Declining activity - 2 submissions in the last 2 years vs 7 in the prior period
Review times increasing: avg 206d recently vs 164d historically

FDA 510(k) Cleared Spirometer, Diagnostic Devices (Product Code BZG)

228 devices
1–24 of 228
Cleared Mar 02, 2026
MESI mTABLET SPIRO
K251777
Mesi D.O.O.
Anesthesiology · 265d
Cleared Nov 20, 2024
TD-7301 Spirometer (TD-7301)
K241843
Gostar Co., Ltd.
Anesthesiology · 147d
Cleared Jan 18, 2024
Air Next (NVD-02)
K231416
Nuvoair AB
Anesthesiology · 247d
Cleared Dec 15, 2023
Spirobank Oxi
K230501
Mir Medical International Research USA
Anesthesiology · 294d
Cleared Oct 19, 2023
EasyOne Sky Spirometer
K230178
Ndd Medizintechnik AG
Anesthesiology · 269d
Cleared Aug 28, 2023
Alveoair Digital Spirometer
K222525
Roundworks Technologies Private Limited
Anesthesiology · 371d
Cleared Aug 09, 2023
Air Smart Extra Spirometer
K222443
Feellife Health, Inc.
Anesthesiology · 362d
Cleared Jun 12, 2023
SpiroHome Personal, SpiroHome Clinic
K213754
Inofab Saglik Teknolojileri A.S
Anesthesiology · 559d
Cleared Jul 15, 2022
ComPAS2
K213872
Morgan Scientific, Inc.
Anesthesiology · 214d
Cleared Jan 26, 2022
Vitalograph Model 6000 Alpha
K212938
Vitalograph (Ireland) , Ltd.
Anesthesiology · 133d
Cleared Jun 10, 2021
Spirometer
K201493
Mehow Innovative, Ltd.
Anesthesiology · 371d
Cleared Dec 04, 2020
GoSpiro
K202837
Monitored Therapeutics, Inc.
Anesthesiology · 70d
Cleared Oct 14, 2020
Spirotrac
K201562
Vitalograph (Ireland) , Ltd.
Anesthesiology · 126d
Cleared Jul 30, 2020
Safey Pocket Spirometer
K201002
Safey Medical Devices Pvt, Ltd.
Anesthesiology · 105d
Cleared Jul 27, 2020
Vitalograph Model 2120 In2itive eDiary
K200550
Vitalograph (Ireland) , Ltd.
Anesthesiology · 146d
Cleared Jan 02, 2020
Air Next
K183089
Nuvoair AB
Anesthesiology · 422d
Cleared Oct 03, 2019
Asthma Monitor AM3
K183479
Eresearch Technology
Anesthesiology · 290d
Cleared Sep 10, 2019
Welch Allyn Diagnostic Cardiology Suite 2.X.X with Spirometry option
K191013
Welch Allyn, Inc.
Anesthesiology · 146d
Cleared Jun 06, 2019
ComPAS2 (Computerized Pulmonary Analysis System)
K190568
Morgan Scientific, Inc.
Anesthesiology · 92d
Cleared Jul 13, 2018
Pulmonx Chartis Tablet Console
K180011
Pulmonx Corporation
Anesthesiology · 192d
Cleared May 01, 1981
BREATH METER
K810437
Fred Sammons, Inc.
Anesthesiology · 71d

About Product Code BZG - Regulatory Context

510(k) Submission Activity

228 total 510(k) submissions under product code BZG since 1977, with 228 receiving FDA clearance (average review time: 165 days).

Submission volume has declined in recent years - 2 submissions in the last 24 months compared to 7 in the prior period.

FDA 510(k) Review Time - BZG Product Code

Recent submissions under BZG have taken an average of 206 days to reach a decision - up from 164 days historically. Manufacturers should account for longer review timelines in current project planning.

BZG devices are reviewed by the Anesthesiology panel. Browse all Anesthesiology devices →