Hailie Sensor NF0106
FDA 510(k) K220622 · Adherium (Nz), Ltd.
510(k) numberK220622
Submission
- Device name
- Hailie Sensor NF0106
- Applicant
- Adherium (Nz), Ltd.
Auckland, NZ - Received
- March 3, 2022
- Decision date
- July 15, 2022
- 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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| K250022 | HeroTracker SenseCAF · Traditional | Voluntis | 06/30/2025SE |
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| K242354 | AllNEBCAF · Traditional | Enchant Tek Co. , Ltd. | 04/29/2025SE |
| 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 |
|---|---|---|
| K222247 | Hailie Sensor NF0110CAF · Traditional | 02/08/2023SE |
| K221994 | Hailie Sensor NF0107 & NF0108CAF · Traditional | 10/04/2022SE |
| K211233 | Hailie Sensor NF0109CAF · Traditional | 08/18/2021SE |
| K182638 | Hailie SensorCAF · Traditional | 06/19/2019SE |
| K182573 | Hailie SensorCAF · Traditional | 06/07/2019SE |
| K181405 | Hailie SensorCAF · Traditional | 12/10/2018SE |
| K180407 | SmartinhalerCAF · Traditional | 07/25/2018SE |
| K173310 | SmartTouchCAF · Traditional | 03/26/2018SE |
| K163485 | SmartTouchCAF · Traditional | 08/30/2017SE |
Questions and answers
When was Hailie Sensor NF0106 cleared by the FDA?
Hailie Sensor NF0106 (K220622) received a 510(k) decision of Substantially Equivalent on July 15, 2022, 134 days after the submission was received.
What is the product code of K220622?
The FDA product code is CAF – Nebulizer (Direct Patient Interface), a Class II (moderate risk) device regulated under 21 CFR 868.5630.