Aluna 2

FDA 510(k) K232588 · Knox Medical Diagnostics

Substantially Equivalent

510(k) numberK232588

Submission

Device name
Aluna 2
Applicant
Knox Medical Diagnostics
San Francisco, CA, US
Received
August 25, 2023
Decision date
November 25, 2024
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
BZH – Meter, Peak Flow, Spirometry
Device class
Class II (moderate risk)
Regulation
21 CFR 868.1860
Specialty
Anesthesiology

Other 510(k)s with product code BZH

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K253180Microlife Digital Peak Flow Meter, Model PF200B (PF200B)BZH · Traditional Microlife Corporation06/23/2026SE
K252802Peak Flow Meter (PF-10(BR-PEF231))BZH · Traditional Shenzhen Bi-Rich Medical Devices Co., Ltd.05/29/2026SE
K241338Peak Flow MeterBZH · Traditional Chongqing Moffy Innovation Technology Co., Ltd.12/31/2024SE
K230423Electronic Peak Flow MeterBZH · Traditional Taian Dalu Medical Instrument Co., Ltd.02/23/2024SE
K222810TD-7301 Peak Flow meterBZH · Traditional Gostar Co., Ltd.12/19/2023SE
K203196Peak flow meterBZH · Traditional Shanghai Sonmol Medical Equipment Co., Ltd.05/26/2021SE
K200832Safey Peak Flow MeterBZH · Traditional Safey Medical Devices Pvt, Ltd.07/30/2020SE
K193311AlunaBZH · Traditional Knox Medical Diagnostics, Inc.03/25/2020SE
K191239Smart Peak Flow MeterBZH · Traditional Guangzhou Homesun Medical Technology Co., Ltd.12/06/2019SE
K180487Peak.meBZH · Traditional Breathe Me, Ltd.10/26/2018SE

More from Breathe Me, Ltd.

510(k)DeviceDecision
K193311AlunaBZH · Traditional 03/25/2020SE

Questions and answers

When was Aluna 2 cleared by the FDA?

Aluna 2 (K232588) received a 510(k) decision of Substantially Equivalent on November 25, 2024, 458 days after the submission was received.

What is the product code of K232588?

The FDA product code is BZH – Meter, Peak Flow, Spirometry, a Class II (moderate risk) device regulated under 21 CFR 868.1860.