Propeller MDI 2 Sensor
Propeller MDI 2 Sensor is an inhaler dose sensor (FDA Class II; FDA product code CAF, Nebulizer (Direct Patient Interface)) made by Reciprocal Labs, cleared under FDA 510(k) K142516 on 15 May 2015 and listed in FDA GUDID since 22 Jul 2016 (UDI-DI 00865528000013), active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00865528000013 | Date22 Jul 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK142516 | Date15 May 2015 | StatusActive |
Official records
- AccessGUDID record 00865528000013
- FDA 510(k) database K142516
Across registries
- FDA 510(k) K142516 decided 15 May 2015 Active
- FDA GUDID UDI-DI 00865528000013 listed 22 Jul 2016 Listed
Timeline
- Cleared FDA 510(k) K142516
- Listed FDA GUDID 00865528000013
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Propeller
- Generic name
- Inhaler dose sensor
- Model / reference
- MDI 2 Sensor
- Primary DI / UDI-DI
- 00865528000013
- 510(k) Number
- FDA product code
- CAF
- GMDN term
- Inhaler dose sensor
- Device class
- Class II
- Regulation number
- 868.5630
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
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