Smart One
FDA 510(k) clearance K181666 · decided 2018-08-01
Clearance details
- K-number
- K181666
- Device name
- Smart One
- Applicant
- Mir Medical International Research
- Decision
- Substantially Equivalent
- Date received
- 2018-06-25
- Decision date
- 2018-08-01
- Days to decision
- 37 days
- Clearance type
- Traditional
- Product code
- BZH
- Device class
- 2
- Regulation number
- 868.1860
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Roma, IT
- Third-party review
- Yes
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Mir Medical International Research
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Microlife Digital Peak Flow Meter, Model PF200B (PF200B) (K253180) | Microlife Corporation | 2026-06-23 |
| Peak Flow Meter (PF-10(BR-PEF231)) (K252802) | Shenzhen Bi-Rich Medical Devices Co., Ltd. | 2026-05-29 |
| Peak Flow Meter (K241338) | Chongqing Moffy Innovation Technology Co., Ltd. | 2024-12-31 |
| Aluna 2 (K232588) | Knox Medical Diagnostics | 2024-11-25 |
| 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 |
| Besmed Peak Flow Meter (K172804) | Besmed Health Business Corp | 2018-01-11 |
Recalls involving this device
No recalls on record reference this clearance.