HeroTracker Sense
FDA 510(k) K250022 · Voluntis
510(k) numberK250022
Submission
- Device name
- HeroTracker Sense
- Applicant
- Voluntis
Paris, FR - Received
- January 3, 2025
- Decision date
- June 30, 2025
- 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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| K251659 | Mesh Nebulizer (H6)CAF · Traditional | Qingdao Future Medical Technology Co., Ltd. | 11/14/2025SE |
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| K232507 | Aerogen®Solo Nebulizer SystemCAF · Traditional | Aerogen, Ltd. | 05/10/2024SE |
| K232523 | Sodium Chloride Inhalation Solution, USP 0.9%, 3% & 7%CAF · Traditional | Mankind Pharma Limited | 04/10/2024SE |
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Questions and answers
When was HeroTracker Sense cleared by the FDA?
HeroTracker Sense (K250022) received a 510(k) decision of Substantially Equivalent on June 30, 2025, 178 days after the submission was received.
What is the product code of K250022?
The FDA product code is CAF – Nebulizer (Direct Patient Interface), a Class II (moderate risk) device regulated under 21 CFR 868.5630.