Propeller System
by Reciprocal Labs Corporation
510(k) K142516
Propeller System is a medical device (FDA Class II; FDA product code CAF, Nebulizer (Direct Patient Interface)) made by Reciprocal Labs Corporation, cleared under FDA 510(k) K142516 on 15 May 2015, 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 | FDA 510(k)SESE | NumberK142516 | Date15 May 2015 | StatusActive |
Official records
- FDA 510(k) database K142516
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- CAF
- Device class
- Class II
- Regulation
- 21 CFR Part 868.5630
- Advisory committee
- Anesthesiology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K142516
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Propeller MDI 2 Sensor | MDI 2 Sensor | 00865528000013 | — | On the market |
| Propeller Sensor Model 2016-M-L | Sensor Model 2016-M-L | 00865528000082 | — | On the market |
| Propeller Sensor Model 2016-M-S | Sensor Model 2016-M-S | 00865528000075 | — | On the market |
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Other devices filed under FDA product code CAF (Nebulizer (Direct Patient Interface)).
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