Propeller System
510(k) K152882
Propeller System is a medical device (FDA Class II; FDA product code CAF, Nebulizer (Direct Patient Interface)) made by Reciprocal Labs, cleared under FDA 510(k) K152882 on 8 Mar 2016, 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 | NumberK152882 | Date8 Mar 2016 | StatusActive |
Official records
- FDA 510(k) database K152882
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- Withdrawn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 K152882
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 Sensor Model 2014-D | Sensor Model 2014-D | 00865528000037 | — | On the market |
Similar devices
Other devices filed under FDA product code CAF (Nebulizer (Direct Patient Interface)).
- ADJUSTABLE ENTRAINMENT NEBULIZER by Automatic Liquid Packaging, Inc.
- Portable Mesh Nebulizer JM821 by Shenzhen Jermei Medical Device Technology Co., Ltd
- THE SWIRLER NEBULIZER by Amici, Inc.
- ICEL ULTRASONIC NEBULIZER MODELS PU 12000 AND PU 12300 by Impulso Trading Co.
- TRUMIST BREATH ACTUATED DISPOSABLE NEBULIZER by Trudell Medical
- GALEMED NEB-EASY NEBULIZER by GaleMed Corporation
- ASTHMAKIT by Dhd Medical Products Div. Diemolding Corp.
- NEBULIZER HEATER by Automatic Liquid Packaging, Inc.
- POCKETSPACER by Ferraris Medical, Inc.
- SALTER LABS 8990 SERIES NEBULIZER by SALTER LABS