510(k) · Cleared
ClearedHumidaire 2I
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Resmed, Ltd. · BTT Humidifier, Respiratory Gas, (Direct Patient Interface)
Cleared on Jul 9, 2008 as substantially equivalent to K013843 (Resmed Corp, 2002) and 1 other predicate after a 111-day review. Its family tree reaches back 3 generations to 1998. 2 later devices descend from it.
- Decided
- Jul 9, 2008
- Review
- 111 days
- Class
- Class II
- Product code
- BTT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K974417 (1998). 6 ancestors in all, the oldest K971260 (1997). 2 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK974417 Sullivan Vpap II ST-a Nasal Vpap SystemResmed Corp · 1998
- 2 generations backK033276 Vpap Iii ST-aResmed, Ltd. · 2004
- 1 generation backK051364 Vpap AdaptResmed, Ltd. · 2005
- This deviceK080797 Humidaire 2IResmed, Ltd. · 2008
- Descendant · cites it directly · 1 of its ownK131388 Transcend Heated HumidifierSomnetics International, Inc. · 2013
- Descendant · 2 generations on · 0 of its ownK180388 Transcend 365 miniCPAP SystemSomnetics International, Inc. · 2018
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K974417 | Sullivan Vpap II ST-a Nasal Vpap System | Resmed Corp | 1998 | — |
| −2 | K033276 | Vpap Iii ST-a | Resmed, Ltd. | 2004 | — |
| −1 | K051364 | Vpap Adapt | Resmed, Ltd. | 2005 | — |
| 0 (this device) | K080797 | Humidaire 2I | Resmed, Ltd. | 2008 | — |
| +1 | K131388 | Transcend Heated Humidifier | Somnetics International, Inc. | 2013 | — |
| +2 | K180388 | Transcend 365 miniCPAP System | Somnetics International, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2018 | 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? (2)
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 |
|---|---|---|---|
| * | K013843 | Autoset Spirit Cpap SystemSummary page 1…me Humidifier, respiratory gas, (direct patient interface) Proprietary Name HumidAire 2iTM Predicate Device(s) AutoSet SpiritTM with H2i (K013843) - Primary VPAP ADAPTTM with H2i (K051 364) Reason for submission New Device l 4 thMarch… | 2002 |
| * | K051364 | Vpap AdaptSummary page 1…Proprietary Name HumidAire 2iTM Predicate Device(s) AutoSet SpiritTM with H2i (K013843) - Primary VPAP ADAPTTM with H2i (K051 364) Reason for submission New Device l 4 thMarch, 2008… | 2005 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K131388 | Transcend Heated Humidifier | 2013 | 1 |
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 10 years and passes through 2 companies; a new generation was cleared every 2.9 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K131388 (Somnetics International, Inc., 2013) has gone furthest, with 1 descendant of its own.
- 6 other devices also cite its predicate K013843.
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. 2008, this device’s year, is highlighted.
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 HumidAire 2i is indicated for the humidification of the air delivered from a ResMed compatible CPAP therapy device.
The HumidAire 2i is intended for single patient re-use in the home environment and multi-patient re-use in a hospital / institutional environment.
The HumidAire 2i is for use only as recommended by a physician.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080797 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080797: Humidaire 2I.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080797
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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