Vapotherm Aerosol Adapter AAA-2
FDA 510(k) K220869 · Vapotherm, Inc.
510(k) numberK220869
Submission
- Device name
- Vapotherm Aerosol Adapter AAA-2
- Applicant
- Vapotherm, Inc.
Exeter, NH, US - Received
- March 25, 2022
- Decision date
- October 28, 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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| K233553 | MiniSpacer® 1024, 1025, 1543 and 1024A, 1025A, 1543A Dual Spray MDI AdapterCAF · Special | Thayer Medical Corporation | 06/18/2024SE |
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| K203357 | HVT 2.0BTT · Traditional | 08/25/2021SE |
| K191010 | Palladium High Flow Therapy SystemBTT · Traditional | 10/10/2019SE |
| K111640 | Precision Flow(R) - HelioxBTT · Traditional | 10/07/2011SE |
| K103316 | FlowrestBTT · Traditional | 02/08/2011SE |
| K072845 | Precision FlowBTT · Traditional | 07/17/2008SE |
| K070056 | Vapotherm Model# 2000I and 2000HBTT · Special | 04/13/2007SE |
| K042245 | Vapotherm MODEL#2000I, 200HBTT · Traditional | 08/30/2004SE |
| K013486 | Vapotherm 2000HBTT · Traditional | 05/30/2003SE |
Questions and answers
When was Vapotherm Aerosol Adapter AAA-2 cleared by the FDA?
Vapotherm Aerosol Adapter AAA-2 (K220869) received a 510(k) decision of Substantially Equivalent on October 28, 2022, 217 days after the submission was received.
What is the product code of K220869?
The FDA product code is CAF – Nebulizer (Direct Patient Interface), a Class II (moderate risk) device regulated under 21 CFR 868.5630.