510(k) · Cleared
ClearedVapotherm, Model 2000I
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 Aug 24, 2000 after a 199-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 11 later devices descend from it.
- Decided
- Aug 24, 2000
- Review
- 199 days
- Class
- Class II
- Product code
- BTT
- Recalls
- None
- Predicates
- 0
11 later devices descend from it, 5 citing it directly.
- This deviceK000401 Vapotherm, Model 2000IVapotherm, Inc. · 2000
- Descendant · cites it directly · 8 of its ownK040862 Guardian Neonate Cpap/Humidification SystemCaradyne, Ltd. · 2004 · Recalled
- Descendant · cites it directly · 7 of its ownK013486 Vapotherm 2000HVapotherm, Inc. · 2003
- Descendant · cites it directly · 6 of its ownK042245 Vapotherm Model#2000I, 200HVapotherm, Inc. · 2004
- Descendant · cites it directly · 2 of its ownK072845 Precision FlowVapotherm, Inc. · 2008 · Recalled
- Descendant · cites it directly · 1 of its ownK050314 AquinoxSmiths Medical Asd, Inc. · 2005
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K040862Guardian Neonate Cpap/Humidification SystemCaradyne, Ltd. · 2004 · cites it directly8descendants
- K013486Vapotherm 2000HVapotherm, Inc. · 2003 · cites it directly7descendants
- K042245Vapotherm Model#2000I, 200HVapotherm, Inc. · 2004 · cites it directly6descendants
- K072845Precision FlowVapotherm, Inc. · 2008 · cites it directly2descendants
- K050314AquinoxSmiths Medical Asd, Inc. · 2005 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K000401 | Vapotherm, Model 2000I | Vapotherm, Inc. | 2000 | — |
| +1 | K040862 | Guardian Neonate Cpap/Humidification System | Caradyne, Ltd. | 2004 | 2 |
| +1 | K013486 | Vapotherm 2000H | Vapotherm, Inc. | 2003 | — |
| +1 | K042245 | Vapotherm Model#2000I, 200H | Vapotherm, Inc. | 2004 | — |
| +1 | K072845 | Precision Flow | Vapotherm, Inc. | 2008 | 8 |
| +1 | K050314 | Aquinox | Smiths Medical Asd, Inc. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2011 | 2 | 0 |
| 2020 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (11)
See all 115 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K040862 (Caradyne, Ltd., 2004) has gone furthest, with 8 descendants of its own.
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 | — |
https://510kreport.com/device/K000401 · printed Nov 6, 2026
Cite this page
510(k) Report. “K000401: Vapotherm, Model 2000I.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K000401
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026