Chrysalis Intelligence · Product Codes · BZH

BZH · Meter, Peak Flow, Spirometry

Anesthesiology · 9 clearances · 8 unique sponsors

Device class
Class II
Regulation 868.1860
Total clearances
9
2020-03-25 → 2026-06-23
Last 12 months
2
Unique sponsors
8
Medical specialty
Anesthesiology
Review panel
AN
Regulation number
868.1860
Implant
N
Life-sustain / support
N
GMP exempt
N
Third-party review
Y
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Knox Medical Diagnostics, Inc. 2 0 2024-11-25
Safey Medical Devices Pvt, Ltd. 1 0 2020-07-30
Taian Dalu Medical Instrument Co., Ltd. 1 0 2024-02-23
Chongqing Moffy Innovation Technology Co., Ltd. 1 0 2024-12-31
Gostar Co., Ltd. 1 0 2023-12-19
Shenzhen Bi-Rich Medical Devices Co., Ltd. 1 1 2026-05-29
Microlife Corporation 1 1 2026-06-23
Shanghai Sonmol Medical Equipment Co., Ltd. 1 0 2021-05-26
Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

CodeTypeDescriptionConfidenceRationale
94060 CPT High Peak expiratory flow (PEF) measurement; standard code for peak flow meter
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-06-23 K253180 Microlife Corporation Microlife Digital Peak Flow Meter, Model PF200B (PF200B)
2026-05-29 K252802 Shenzhen Bi-Rich Medical Devices Co., Ltd. Peak Flow Meter (PF-10(BR-PEF231))
2024-12-31 K241338 Chongqing Moffy Innovation Technology Co., Ltd. Peak Flow Meter
2024-11-25 K232588 Knox Medical Diagnostics Aluna 2
2024-02-23 K230423 Taian Dalu Medical Instrument Co., Ltd. Electronic Peak Flow Meter
2023-12-19 K222810 Gostar Co., Ltd. TD-7301 Peak Flow meter
2021-05-26 K203196 Shanghai Sonmol Medical Equipment Co., Ltd. Peak flow meter
2020-07-30 K200832 Safey Medical Devices Pvt, Ltd. Safey Peak Flow Meter
2020-03-25 K193311 Knox Medical Diagnostics, Inc. Aluna