Propeller Sensor Model 2015-E
Propeller Sensor Model 2015-E 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) K161454 on 1 Nov 2016 and listed in FDA GUDID since 16 Jan 2017 (UDI-DI 00865528000068), 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 | Number00865528000068 | Date16 Jan 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK161454 | Date1 Nov 2016 | StatusActive |
Official records
- AccessGUDID record 00865528000068
- FDA 510(k) database K161454
Across registries
- FDA 510(k) K161454 decided 1 Nov 2016 Active
- FDA GUDID UDI-DI 00865528000068 listed 16 Jan 2017 Listed
Timeline
- Cleared FDA 510(k) K161454
- Listed FDA GUDID 00865528000068
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Propeller
- Generic name
- Inhaler dose sensor
- Model / reference
- Sensor Model 2015-E
- Primary DI / UDI-DI
- 00865528000068
- 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
Similar devices
Other devices filed under FDA product code CAF (Nebulizer (Direct Patient Interface)).
- BIRDSONG LEVERHALER, MODEL LH-1000 by Birdsong Medical Devices, Inc.
- MICROFLOW by Mountain Medical Equipment, Inc.
- PATIENT CIRCUIT MANIFOLD by Bourns Medical Systems, Inc.
- AERO-MIST NEBULIZER HEATER by Pegasus Research Corp.
- AEROVENT II CHC COLLAPSIBLE HOLDING CHAMBER by MONAGHAN MEDICAL CORP.
- THERA-MIST(TM) NEBULIZER, MODEL 30000 by Pegasus Research Corp.
- DEVILBISS PULMO-AIDE COMPACT COMPRESSOR by Sunrise Medical
- DEVILBISS MODEL 8500D by The Devilbiss Co.
- U-MID PREFILLED NEBULIZER by Bd Becton Dickinson Vacutainer Systems Preanalytic
- U-RIGHT COMPRESSOR NEBULIZER by TAIDOC TECHNOLOGY CORPORATION