510(k) · Cleared
ClearedVapotherm Model#2000I, 200H
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 30, 2004 as substantially equivalent to K000401 (Vapotherm, Inc., 2000) and 2 other predicates after an 11-day review. Its family tree reaches back 2 generations to 2000. 6 later devices descend from it.
- Decided
- Aug 30, 2004
- Review
- 11 days
- Class
- Class II
- Product code
- BTT
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K000401 (2000). 4 ancestors in all. 6 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK000401 Vapotherm, Model 2000IVapotherm, Inc. · 2000
- 1 generation backK013486 Vapotherm 2000HVapotherm, Inc. · 2003
- This deviceK042245 Vapotherm Model#2000I, 200HVapotherm, Inc. · 2004
- Descendant · cites it directly · 2 of its ownK072845 Precision FlowVapotherm, Inc. · 2008 · Recalled
- Descendant · 2 generations on · 0 of its ownK254078 HVT 2.0Vapotherm, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK193411 O2asis Personal Oxygen HumidifierPerma Pure, LLC · 2020
- Descendant · 2 generations on · 0 of its ownK111640 Precision Flow (R) - HelioxVapotherm, Inc. · 2011 · Recalled
- Descendant · cites it directly · 0 of its ownK070056 Vapotherm Model# 2000I and 2000HVapotherm, Inc. · 2007
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K072845Precision FlowVapotherm, Inc. · 2008 · cites it directly2descendants
- K254078HVT 2.0Vapotherm, Inc. · 2026 · 2 generations on0descendants
- K193411O2asis Personal Oxygen HumidifierPerma Pure, LLC · 2020 · cites it directly0descendants
- K111640Precision Flow (R) - HelioxVapotherm, Inc. · 2011 · 2 generations on0descendants
- K070056Vapotherm Model# 2000I and 2000HVapotherm, Inc. · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K000401 | Vapotherm, Model 2000I | Vapotherm, Inc. | 2000 | — |
| −1 | K013486 | Vapotherm 2000H | Vapotherm, Inc. | 2003 | — |
| 0 (this device) | K042245 | Vapotherm Model#2000I, 200H | Vapotherm, Inc. | 2004 | — |
| +1 | K072845 | Precision Flow | Vapotherm, Inc. | 2008 | 8 |
| +2 | K254078 | HVT 2.0 | Vapotherm, Inc. | 2026 | — |
| +1 | K193411 | O2asis Personal Oxygen Humidifier | Perma Pure, LLC | 2020 | — |
| +2 | K111640 | Precision Flow (R) - Heliox | Vapotherm, Inc. | 2011 | 1 |
| +1 | K070056 | Vapotherm Model# 2000I and 2000H | Vapotherm, Inc. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (3)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K000401 | Vapotherm, Model 2000ISummary page 1…Respiratory Gas (Direct Patient Interface) Device: Vapotherm' TM 2000h and 2000i Predicate Devices: VapothermT M 2000h, K000401, and 2000i - K013486 Caradyne Guardian - K040862 IDevice Description: The Vapotherm 20… | 2000 |
| * | K013486 | Vapotherm 2000HSummary page 1…ect Patient Interface) Device: Vapotherm' TM 2000h and 2000i Predicate Devices: VapothermT M 2000h, K000401, and 2000i - K013486 Caradyne Guardian - K040862 IDevice Description: The Vapotherm 2000i and Vapotherm 200… | 2003 |
| * | K040862 | Guardian Neonate Cpap/Humidification SystemSummary page 1…therm' TM 2000h and 2000i Predicate Devices: VapothermT M 2000h, K000401, and 2000i - K013486 Caradyne Guardian - K040862 IDevice Description: The Vapotherm 2000i and Vapotherm 2000h are identical and share the concept of humidification by tran… | 2004 |
What descends from it? (6)
4 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?
- The line of descent spans 4 years and passes through 1 company; a new generation was cleared every 2.8 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K072845 (Vapotherm, Inc., 2008) has gone furthest, with 2 descendants of its own.
- 4 other devices also cite its predicate K000401.
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 and 2000i are designed to add moisture to and to warm breathing gases for administration to patients, including neonates/infant, pediatrics, and adults. The flow rates may be from 1 to 40 liters per minute via nasal cannula.
Environments of use - Home, Hospital, Sub-acute Institutions
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042245 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042245: Vapotherm Model#2000I, 200H.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042245
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026