510(k) · Cleared
ClearedTranscend Heated Humidifier
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Somnetics International, Inc. · BTT Humidifier, Respiratory Gas, (Direct Patient Interface)
Cleared on Sep 26, 2013 as substantially equivalent to K080797 (Resmed, Ltd., 2008) after a 135-day review. Its family tree reaches back 4 generations to 1998. 1 later device descends from it.
- Decided
- Sep 26, 2013
- Review
- 135 days
- Class
- Class II
- Product code
- BTT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K974417 (1998). 7 ancestors in all, the oldest K971260 (1997). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK974417 Sullivan Vpap II ST-a Nasal Vpap SystemResmed Corp · 1998
- 3 generations backK033276 Vpap Iii ST-aResmed, Ltd. · 2004
- 2 generations backK051364 Vpap AdaptResmed, Ltd. · 2005
- 1 generation backK080797 Humidaire 2IResmed, Ltd. · 2008
- This deviceK131388 Transcend Heated HumidifierSomnetics International, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK180388 Transcend 365 miniCPAP SystemSomnetics International, Inc. · 2018
Most influential descendants
Showing 1 of 1 · See all- K180388Transcend 365 miniCPAP SystemSomnetics International, Inc. · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K974417 | Sullivan Vpap II ST-a Nasal Vpap System | Resmed Corp | 1998 | — |
| −3 | K033276 | Vpap Iii ST-a | Resmed, Ltd. | 2004 | — |
| −2 | K051364 | Vpap Adapt | Resmed, Ltd. | 2005 | — |
| −1 | K080797 | Humidaire 2I | Resmed, Ltd. | 2008 | — |
| 0 (this device) | K131388 | Transcend Heated Humidifier | Somnetics International, Inc. | 2013 | — |
| +1 | 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 |
|---|---|---|
| 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K080797 | Humidaire 2ISummary page 4…These tests and assessments did not raise new safety or efficacy questions. Conclusion The Transcend Heated Humidifier is substantially equivalent to the HumidAire 2i (K080797). The subject and predicate devices are used in conjunction with CPAP devices to humidify air. They are equivalent in terms of te… | 2008 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K180388 | Transcend 365 miniCPAP System | 2018 | 0 |
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 15 years and passes through 3 companies; a new generation was cleared every 5.2 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K180388 (Somnetics International, Inc., 2018) has gone furthest, with 0 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. 2013, 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 Transcend Heated Humidifier is indicated for the humidification of the air delivered from a compatible Transcend positive airway pressure therapy device. The Humidifier is intended for single patient re-use in the home environment and in a hospital/institutional environment. The Humidifier is for use only as recommended by a physician.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131388 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131388: Transcend Heated Humidifier.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131388
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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