Chrysalis Intelligence · Product Codes · BZG

BZG · Spirometer, Diagnostic

Anesthesiology · 16 clearances · 13 unique sponsors

Device class
Class II
Regulation 868.1840
Total clearances
16
2020-01-02 → 2026-03-02
Last 12 months
1
Unique sponsors
13
Medical specialty
Anesthesiology
Review panel
AN
Regulation number
868.1840
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
Vitalograph Ireland, Ltd. 3 0 2022-01-26
Nuvoair AB 2 0 2024-01-18
Inofab Saglik Teknolojileri A.S 1 0 2023-06-12
Safey Medical Devices Pvt, Ltd. 1 0 2020-07-30
Ndd Medizintechnik AG 1 0 2023-10-19
Mesi D.O.O. 1 1 2026-03-02
Monitored Therapeutics, Inc. 1 0 2020-12-04
Mir Medical International Research USA 1 0 2023-12-15
Roundworks Technologies Private Limited 1 0 2023-08-28
Feellife Health, Inc. 1 0 2023-08-09
Morgan Scientific, Inc. 1 0 2022-07-15
Gostar Co., Ltd. 1 0 2024-11-20
Mehow Innovative, Ltd. 1 0 2021-06-10
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
94010 CPT High Spirometry; standard diagnostic pulmonary function test code
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-03-02 K251777 Mesi D.O.O. MESI mTABLET SPIRO
2024-11-20 K241843 Gostar Co., Ltd. TD-7301 Spirometer (TD-7301)
2024-01-18 K231416 Nuvoair AB Air Next (NVD-02)
2023-12-15 K230501 Mir Medical International Research USA Spirobank Oxi
2023-10-19 K230178 Ndd Medizintechnik AG EasyOne Sky Spirometer
2023-08-28 K222525 Roundworks Technologies Private Limited Alveoair Digital Spirometer
2023-08-09 K222443 Feellife Health, Inc. Air Smart Extra Spirometer
2023-06-12 K213754 Inofab Saglik Teknolojileri A.S SpiroHome Personal, SpiroHome Clinic
2022-07-15 K213872 Morgan Scientific, Inc. ComPAS2
2022-01-26 K212938 Vitalograph Ireland, Ltd. Vitalograph Model 6000 Alpha
2021-06-10 K201493 Mehow Innovative, Ltd. Spirometer
2020-12-04 K202837 Monitored Therapeutics, Inc. GoSpiro
2020-10-14 K201562 Vitalograph Ireland, Ltd. Spirotrac
2020-07-30 K201002 Safey Medical Devices Pvt, Ltd. Safey Pocket Spirometer
2020-07-27 K200550 Vitalograph Ireland, Ltd. Vitalograph Model 2120 In2itive eDiary
2020-01-02 K183089 Nuvoair AB Air Next