Vapotherm 2000H
FDA 510(k) K013486 · Vapotherm, Inc.
510(k) numberK013486
Submission
- Device name
- Vapotherm 2000H
- Applicant
- Vapotherm, Inc.
Mccordsville, IN, US - Received
- October 19, 2001
- Decision date
- May 30, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- BTT – Humidifier, Respiratory Gas, (Direct Patient Interface)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5450
- Specialty
- Anesthesiology
Other 510(k)s with product code BTT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262268 | Optiflow Oxygen Kit (AA484J)BTT · Special | Fisher and Paykel Healthcare Limited | 08/27/2026SE |
| K254078 | HVT 2.0BTT · Traditional | Vapotherm, Inc. | 04/13/2026SE |
| K251448 | FL-10000U Respiratory HumidifierBTT · Traditional | Flexicare Medical Limited. | 01/16/2026SE |
| K251419 | Laboratorios Biogalenic Sterile Water for Inhalation, USPBTT · Traditional | Laboratorios Biogalenic S.A. DE C.V. | 01/14/2026SE |
| K253479 | Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J)BTT · Special | Fisher & Paykel Healthcare, Ltd. | 12/19/2025SE |
| K250312 | Hudson RCI® Comfort Flo Nasal Cannula Premature, Infant; Hudson RCI® Comfort Flo Plus…BTT · Traditional | Medline Industries, LP | 07/02/2025SE |
| K251611 | Optiflow+ Nasal Cannula - Small (OPT942); Optiflow+ Nasal Cannula - Medium (OPT944)…BTT · Special | Fisher & Paykel Healthcare, Ltd. | 06/25/2025SE |
| K242717 | Laboratorios Biogalenic Sterile Water for Inhalation, USPBTT · Traditional | Laboratorios Biogalenic S.A. DE C.V. | 01/30/2025SE |
| K241778 | Hudson RCI Comfort Flo® CubCannulaBTT · Traditional | Medline Industries, LP | 12/19/2024SE |
| K240163 | Hudson RCI® Comfort Flo Nasal Cannula; Hudson RCI® Comfort Flo Plus CannulaBTT · Traditional | Medline Industries, LP | 09/27/2024SE |
More from Medline Industries, LP
| 510(k) | Device | Decision |
|---|---|---|
| K254078 | HVT 2.0BTT · Traditional | 04/13/2026SE |
| K221318 | HVT 2.0QAV · Traditional | 12/13/2022SE |
| K220869 | Vapotherm Aerosol Adapter AAA-2CAF · Traditional | 10/28/2022SE |
| 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 |
Questions and answers
When was Vapotherm 2000H cleared by the FDA?
Vapotherm 2000H (K013486) received a 510(k) decision of Substantially Equivalent on May 30, 2003, 588 days after the submission was received.
What is the product code of K013486?
The FDA product code is BTT – Humidifier, Respiratory Gas, (Direct Patient Interface), a Class II (moderate risk) device regulated under 21 CFR 868.5450.