Propeller Sensor Model 2015-E
FDA 510(k) K161454 · Reciprocal Labs Corporation
510(k) numberK161454
Submission
- Device name
- Propeller Sensor Model 2015-E
- Applicant
- Reciprocal Labs Corporation
Madison, WI, US - Received
- May 26, 2016
- Decision date
- November 1, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CAF – Nebulizer (Direct Patient Interface)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5630
- Specialty
- Anesthesiology
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| K233553 | MiniSpacer® 1024, 1025, 1543 and 1024A, 1025A, 1543A Dual Spray MDI AdapterCAF · Special | Thayer Medical Corporation | 06/18/2024SE |
| K232507 | Aerogen®Solo Nebulizer SystemCAF · Traditional | Aerogen, Ltd. | 05/10/2024SE |
More from Aerogen, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K192724 | Propeller Sensor for SymbicortCAF · Traditional | 03/26/2020SE |
| K180770 | Propeller Sensor for NeohalerCAF · Traditional | 08/01/2018SE |
| K152882 | Propeller SystemCAF · Traditional | 03/08/2016SE |
| K152482 | Propeller Sensor Model 2014-RCAF · Traditional | 03/04/2016SE |
| K143671 | Propeller Model 2014-D SensorCAF · Traditional | 06/19/2015SE |
| K142516 | Propeller SystemCAF · Traditional | 05/15/2015SE |
| K142960 | Propeller System 2014-RCAF · Traditional | 03/05/2015SE |
| K140638 | Propeller System - Model 2CAF · Traditional | 05/02/2014SE |
| K121609 | Asthmapolis SystemCAF · Traditional | 07/02/2012SE |
Questions and answers
When was Propeller Sensor Model 2015-E cleared by the FDA?
Propeller Sensor Model 2015-E (K161454) received a 510(k) decision of Substantially Equivalent on November 1, 2016, 159 days after the submission was received.
What is the product code of K161454?
The FDA product code is CAF – Nebulizer (Direct Patient Interface), a Class II (moderate risk) device regulated under 21 CFR 868.5630.