Propeller Sensor Model 2014-R
510(k) K152482
Propeller Sensor Model 2014-R is a medical device (FDA Class II; FDA product code CAF, Nebulizer (Direct Patient Interface)) made by Reciprocal Labs, cleared under FDA 510(k) K152482 on 4 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 | NumberK152482 | Date4 Mar 2016 | StatusActive |
Official records
- FDA 510(k) database K152482
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- Withdrawn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
Similar devices
Other devices filed under FDA product code CAF (Nebulizer (Direct Patient Interface)).
- I-Neb AAD System with TIM; I-Neb Insight AAD System by RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD
- MINISPACER 1534 1543 by THAYER MEDICAL CORPORATION
- Steri-Cath MDI by Concord/Portex
- Neb-U-Mask System, Models 1895, 1896 by Teleflex Medical, LLC
- MRT DISPENSOR by Mcgaw Respiratory Therapy
- DHD ACE With Mask Kit by Dhd Diemolding Healthcare Div.
- Salter Labs 8960 Series Nebulizer (8960/8961/8966/8984) by SALTER LABS
- SALTER LABS PEP DEVICE by SALTER LABS
- MILLIPORE RT-100 AEROSOL RETENTION FILTER by Sterimatics Co.
- AeroLife Ultrasonic Nebulizer Model P2C by Aerovectrx Corporation