BZH · Class II · 21 CFR 868.1860

FDA Product Code BZH: Meter, Peak Flow, Spirometry

Leading manufacturers include Besmed Health Business Corp, Breathe Me, Ltd. and Mir Medical International Research.

81
Total
81
Cleared
205d
Avg days
1977
Since
Growing category - 4 submissions in the last 2 years vs 2 in the prior period
Review times increasing: avg 307d recently vs 200d historically

FDA 510(k) Cleared Meter, Peak Flow, Spirometry Devices (Product Code BZH)

81 devices
1–24 of 81
Cleared May 29, 2026
Peak Flow Meter (PF-10(BR-PEF231))
K252802
Shenzhen Bi-Rich Medical Devices Co., Ltd.
Anesthesiology · 268d
Cleared Dec 31, 2024
Peak Flow Meter
K241338
Chongqing Moffy Innovation Technology Co., Ltd.
Anesthesiology · 232d
Cleared Nov 25, 2024
Aluna 2
K232588
Knox Medical Diagnostics
Anesthesiology · 458d
Cleared Feb 23, 2024
Electronic Peak Flow Meter
K230423
Taian Dalu Medical Instrument Co., Ltd.
Anesthesiology · 371d
Cleared Dec 19, 2023
TD-7301 Peak Flow meter
K222810
Gostar Co., Ltd.
Anesthesiology · 459d
Cleared May 26, 2021
Peak flow meter
K203196
Shanghai Sonmol Medical Equipment Co., Ltd.
Anesthesiology · 210d
Cleared Jul 30, 2020
Safey Peak Flow Meter
K200832
Safey Medical Devices Pvt, Ltd.
Anesthesiology · 122d
Cleared Mar 25, 2020
Aluna
K193311
Knox Medical Diagnostics, Inc.
Anesthesiology · 117d
Cleared Dec 06, 2019
Smart Peak Flow Meter
K191239
Guangzhou Homesun Medical Technology Co., Ltd.
Anesthesiology · 212d
Cleared Oct 26, 2018
Peak.me
K180487
Breathe Me, Ltd.
Anesthesiology · 245d
Cleared Aug 01, 2018
Smart One
K181666
Mir Medical International Research
Anesthesiology · 37d
Cleared Jan 11, 2018
Besmed Peak Flow Meter
K172804
Besmed Health Business Corp
Anesthesiology · 115d

About Product Code BZH - Regulatory Context

510(k) Submission Activity

81 total 510(k) submissions under product code BZH since 1977, with 81 receiving FDA clearance (average review time: 205 days).

Submission volume has increased in recent years - 4 submissions in the last 24 months compared to 2 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - BZH Product Code

Recent submissions under BZH have taken an average of 307 days to reach a decision - up from 200 days historically. Manufacturers should account for longer review timelines in current project planning.

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