510(k) · Cleared
ClearedVapotherm 2000H
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vapotherm, Inc. · BTT Humidifier, Respiratory Gas, (Direct Patient Interface)
Cleared on May 30, 2003 as substantially equivalent to K000401 (Vapotherm, Inc., 2000) after a 588-day review. Its family tree reaches back 1 generation to 2000. 7 later devices descend from it.
- Decided
- May 30, 2003
- Review
- 588 days
- Class
- Class II
- Product code
- BTT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K000401 (2000). 7 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK000401 Vapotherm, Model 2000IVapotherm, Inc. · 2000
- This deviceK013486 Vapotherm 2000HVapotherm, Inc. · 2003
- Descendant · cites it directly · 6 of its ownK042245 Vapotherm Model#2000I, 200HVapotherm, Inc. · 2004
- Descendant · 2 generations on · 2 of its ownK072845 Precision FlowVapotherm, Inc. · 2008 · Recalled
- Descendant · 3 generations on · 0 of its ownK254078 HVT 2.0Vapotherm, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK193411 O2asis Personal Oxygen HumidifierPerma Pure, LLC · 2020
- Descendant · 3 generations on · 0 of its ownK111640 Precision Flow (R) - HelioxVapotherm, Inc. · 2011 · Recalled
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K042245Vapotherm Model#2000I, 200HVapotherm, Inc. · 2004 · cites it directly6descendants
- K072845Precision FlowVapotherm, Inc. · 2008 · 2 generations on2descendants
- K254078HVT 2.0Vapotherm, Inc. · 2026 · 3 generations on0descendants
- K193411O2asis Personal Oxygen HumidifierPerma Pure, LLC · 2020 · 2 generations on0descendants
- K111640Precision Flow (R) - HelioxVapotherm, Inc. · 2011 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K000401 | Vapotherm, Model 2000I | Vapotherm, Inc. | 2000 | — |
| 0 (this device) | K013486 | Vapotherm 2000H | Vapotherm, Inc. | 2003 | — |
| +1 | K042245 | Vapotherm Model#2000I, 200H | Vapotherm, Inc. | 2004 | — |
| +2 | K072845 | Precision Flow | Vapotherm, Inc. | 2008 | 8 |
| +3 | K254078 | HVT 2.0 | Vapotherm, Inc. | 2026 | — |
| +2 | K193411 | O2asis Personal Oxygen Humidifier | Perma Pure, LLC | 2020 | — |
| +3 | K111640 | Precision Flow (R) - Heliox | Vapotherm, Inc. | 2011 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2020 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in BTT? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new BTT device
- #1 K222197 F&P Optiflow Junior 2/2+ Nasal Cannula…score 16.8 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K042245 | Vapotherm Model#2000I, 200H | 2004 | 6 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All BTT devicesBTT Humidifier, Respiratory Gas, (Direct Patient Interface): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · BTT
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · BTT
104in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BTT
1in 2025
Class I (4 since 2007) Class II/III not classified
Adverse event reports per year · BTT
1,743in 2025
MAUDE reports naming product code BTT, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 6 | 73 | 1 | 365 |
| 2008 | 4 | 199 | 1 | 456 |
| 2009 | 1 | — | 0 | 558 |
| 2010 | 4 | 113 | 2 | 562 |
| 2011 | 3 | 116 | 1 | 665 |
| 2012 | 2 | — | 0 | 583 |
| 2013 | 6 | 171 | 0 | 718 |
| 2014 | 7 | 231 | 5 (4) | 718 |
| 2015 | 1 | — | 0 | 670 |
| 2016 | 3 | 157 | 0 | 1,094 |
| 2017 | 3 | 303 | 0 | 1,007 |
| 2018 | 2 | — | 0 | 918 |
| 2019 | 1 | — | 0 | 894 |
| 2020 | 2 | — | 0 | 1,188 |
| 2021 | 2 | — | 0 | 1,510 |
| 2022 | 3 | 290 | 0 | 749 |
| 2023 | 7 | 258 | 0 | 716 |
| 2024 | 7 | 219 | 0 | 501 |
| 2025 | 4 | 104 | 1 | 1,743 |
| 2026 | 4 | 184 | 1 | — |
What is it indicated for?
The Vapotherm 2000h (5000) can mix air with oxygen from an external source and adds heat and moisture to the gas. The Vapotherm 2000h (5000) is for use in home, hospital or sub-acute institutional settings.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K013486 · printed Nov 4, 2026
Cite this page
510(k) Report. “K013486: Vapotherm 2000H.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K013486
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026