Aluna 2
FDA 510(k) clearance K232588 · decided 2024-11-25
Clearance details
- K-number
- K232588
- Device name
- Aluna 2
- Applicant
- Knox Medical Diagnostics
- Decision
- Substantially Equivalent
- Date received
- 2023-08-25
- Decision date
- 2024-11-25
- Days to decision
- 458 days
- Clearance type
- Traditional
- Product code
- BZH
- Device class
- 2
- Regulation number
- 868.1860
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- San Francisco, CA, US
- Third-party review
- No
- Expedited review
- No
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|---|---|---|
| Microlife Digital Peak Flow Meter, Model PF200B (PF200B) (K253180) | Microlife Corporation | 2026-06-23 |
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| Peak Flow Meter (K241338) | Chongqing Moffy Innovation Technology Co., Ltd. | 2024-12-31 |
| Electronic Peak Flow Meter (K230423) | Taian Dalu Medical Instrument Co., Ltd. | 2024-02-23 |
| TD-7301 Peak Flow meter (K222810) | Gostar Co., Ltd. | 2023-12-19 |
| Peak flow meter (K203196) | Shanghai Sonmol Medical Equipment Co., Ltd. | 2021-05-26 |
| Safey Peak Flow Meter (K200832) | Safey Medical Devices Pvt, Ltd. | 2020-07-30 |
| Aluna (K193311) | Knox Medical Diagnostics, Inc. | 2020-03-25 |
| Smart Peak Flow Meter (K191239) | Guangzhou Homesun Medical Technology Co., Ltd. | 2019-12-06 |
| Peak.me (K180487) | Breathe Me, Ltd. | 2018-10-26 |
| Smart One (K181666) | Mir Medical International Research | 2018-08-01 |
| Besmed Peak Flow Meter (K172804) | Besmed Health Business Corp | 2018-01-11 |
Recalls involving this device
No recalls on record reference this clearance.