510(k) · Cleared
ClearedSullivan Humidaire Heated Humidifier
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Resmed Corp · BTT Humidifier, Respiratory Gas, (Direct Patient Interface)
Cleared on Sep 4, 1997 after a 153-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 13 of the 139 devices in its family, counting itself, have a Class I recall. 138 later devices descend from it.
- Decided
- Sep 4, 1997
- Review
- 153 days
- Class
- Class II
- Product code
- BTT
- Recalls
- None
- Predicates
- 0
138 later devices descend from it, 2 citing it directly. 13 of the 139 devices in this family, counting this one, have a Class I recall.
- This deviceK971260 Sullivan Humidaire Heated HumidifierResmed Corp · 1997
- Descendant · cites it directly · 128 of its ownK013909 S7 Elite CP AP SystemResmed Corp · 2002
- Descendant · cites it directly · 125 of its ownK013843 Autoset Spirit Cpap SystemResmed Corp · 2002
- Descendant · 2 generations on · 110 of its ownK024191 S7 Elite and Autoset Spirit Cpap Systems with ReslinkResmed, Ltd. · 2003
- Descendant · 2 generations on · 106 of its ownK030843 Vpap IiiResmed, Ltd. · 2003
- Descendant · 3 generations on · 100 of its ownK033841 Resmed S8 Prime Cpap SystemResmed, Ltd. · 2004 · Recalled
Showing 5 of 138 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 138 · See all- K013909S7 Elite CP AP SystemResmed Corp · 2002 · cites it directly128descendants
- K013843Autoset Spirit Cpap SystemResmed Corp · 2002 · cites it directly125descendants
- K024191S7 Elite and Autoset Spirit Cpap Systems with ReslinkResmed, Ltd. · 2003 · 2 generations on110descendants
- K030843Vpap IiiResmed, Ltd. · 2003 · 2 generations on106descendants
- K033841Resmed S8 Prime Cpap SystemResmed, Ltd. · 2004 · 3 generations on100descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K971260 | Sullivan Humidaire Heated Humidifier | Resmed Corp | 1997 | — |
| +1 | K013909 | S7 Elite CP AP System | Resmed Corp | 2002 | — |
| +1 | K013843 | Autoset Spirit Cpap System | Resmed Corp | 2002 | — |
| +2 | K024191 | S7 Elite and Autoset Spirit Cpap Systems with Reslink | Resmed, Ltd. | 2003 | — |
| +2 | K030843 | Vpap Iii | Resmed, Ltd. | 2003 | — |
| +3 | K033841 | Resmed S8 Prime Cpap System | Resmed, Ltd. | 2004 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 2 | 0 |
| 2003 | 3 | 0 |
| 2004 | 4 | 0 |
| 2005 | 3 | 0 |
| 2006 | 4 | 0 |
| 2007 | 5 | 0 |
| 2008 | 5 | 0 |
| 2009 | 12 | 1 |
| 2010 | 4 | 1 |
| 2011 | 9 | 3 |
| 2012 | 15 | 3 |
| 2013 | 11 | 3 |
| 2014 | 9 | 0 |
| 2015 | 4 | 0 |
| 2016 | 8 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 3 | 1 |
| 2020 | 6 | 0 |
| 2021 | 3 | 1 |
| 2022 | 3 | 0 |
| 2023 | 1 | 0 |
| 2024 | 4 | 0 |
| 2025 | 8 | 0 |
| 2026 | 9 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
13 devices in this family have a Class I recall. 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’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (138)
See all 1382 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (13 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K102465Bipap Avaps Ventilatory Support SystemRespironics, Inc. · 2011 · 3 generations on · ◆ in the 2011 descendants bar of FIG. 11 Class I recall
- K091319Remstar Auto a-FlexRespironics Inc., Sleep & Home Respiratory Group · 2009 · 4 generations on · ◆ in the 2009 descendants bar of FIG. 11 Class I recall
- K111378Oximetry Interface KitPhilips Respironics, Inc. · 2011 · 4 generations on · ◆ in the 2011 descendants bar of FIG. 11 Class I recall
- K092818Bipap Avaps Ventilatory Support SystemRespironics, Inc. · 2010 · 5 generations on · ◆ in the 2010 descendants bar of FIG. 11 Class I recall
- K113068Remstar Auto a-Flex HTRespironics, Inc. · 2011 · 5 generations on · ◆ in the 2011 descendants bar of FIG. 12 Class I recalls
- K113053Bipap a 30 Ventilatory Support SystemRespironics, Inc. · 2012 · 6 generations on · ◆ in the 2012 descendants bar of FIG. 15 Class I recalls
- K131982Remstar Auto a-Flex HTRespironics, Inc. · 2013 · 6 generations on · ◆ in the 2013 descendants bar of FIG. 15 Class I recalls
- K122769Remstar SERespironics, Inc. · 2012 · 6 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
- K121623Bipap a 40 Ventilatory Support SystemRespironics, Inc. · 2012 · 7 generations on · ◆ in the 2012 descendants bar of FIG. 13 Class I recalls
- K130077Remstar SERespironics, Inc. · 2013 · 7 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
- K122715Stellar 150Resmed Germany, Inc. · 2013 · 8 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
- K181166Trilogy EvoRespironics, Inc. · 2019 · 8 generations on · ◆ in the 2019 descendants bar of FIG. 131 Class I recalls
Nearest 12 of 13 shown.
Nearest 5 of 13; all are on the web page.
What does this lineage say?
- Of its descendants, K013909 (Resmed Corp, 2002) has gone furthest, with 128 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 | — |
What is it indicated for?
The HumidAire™ Heated Humidifier is indicated for the humidification and warming of the air from nasal Continuous Positive Airway Pressure (CPAP) and bi-level systems, but not autoset systems. The HumidAire is for prescription use only.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K971260 · printed Nov 4, 2026
Cite this page
510(k) Report. “K971260: Sullivan Humidaire Heated Humidifier.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K971260
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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