Ultrasonic Nebulizer (Mesh Type)
FDA 510(k) K121520 · K-Jump Health Co., Ltd.
510(k) numberK121520
Submission
- Device name
- Ultrasonic Nebulizer (Mesh Type)
- Applicant
- K-Jump Health Co., Ltd.
New Taipei, TW - Received
- May 22, 2012
- Decision date
- March 15, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 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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| K251572 | eRapid with eTrack SystemCAF · Traditional | Pari Respiratory Equipment, Inc. | 12/19/2025SE |
| K251659 | Mesh Nebulizer (H6)CAF · Traditional | Qingdao Future Medical Technology Co., Ltd. | 11/14/2025SE |
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| K250022 | HeroTracker SenseCAF · Traditional | Voluntis | 06/30/2025SE |
| K250583 | AdheResp Smart Breath-actuated Mesh NebulizerCAF · Traditional | Hcmed Innovations Co., Ltd. | 06/20/2025SE |
| 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 |
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| K141505 | Basal Digital ThermometerFLL · Special | 08/26/2014SE |
| K120711 | Non-Contact ThermometerFLL · Traditional | 11/19/2012SE |
| K103617 | Digital Forehead ThermometerFLL · Special | 04/04/2011SE |
| K102947 | Non-Contact Infrared ThermometerFLL · Traditional | 02/25/2011SE |
| K092335 | Peak Expiratory Flow Meter, KN-9710BZH · Traditional | 04/09/2010SE |
| K092806 | Auto Digital Upper Arm Blood Pressure Monitor, Model KP-7770DXN · Special | 10/09/2009SE |
| K083256 | Ultrasonic Nebulizer System, Model KN-9210CAF · Abbreviated | 06/26/2009SE |
| K083753 | Smart-Logic Auto Digital Upperarm Blood Pressure Monitor, Model KP-7500, Fully Fuzzy…DXN · Abbreviated | 06/19/2009SE |
Questions and answers
When was Ultrasonic Nebulizer (Mesh Type) cleared by the FDA?
Ultrasonic Nebulizer (Mesh Type) (K121520) received a 510(k) decision of Substantially Equivalent on March 15, 2013, 297 days after the submission was received.
What is the product code of K121520?
The FDA product code is CAF – Nebulizer (Direct Patient Interface), a Class II (moderate risk) device regulated under 21 CFR 868.5630.