510(k) · Cleared
ClearedH2 Heated Humidifier
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Respironics, Inc. · BTT Humidifier, Respiratory Gas, (Direct Patient Interface)
Cleared on Jan 24, 2003 as substantially equivalent to K012633 (Respironics, Inc., 2002) and 1 other predicate after a 14-day review. Its family tree reaches back 2 generations to 1993. 3 later devices descend from it.
- Decided
- Jan 24, 2003
- Review
- 14 days
- Class
- Class II
- Product code
- BTT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K915460 (1993). 3 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK915460 Heated Respiratory Humidifier HC100Fisher & Paykel Electronics, Ltd. · 1993
- 1 generation backK012633 Respironics Heated HumidifierRespironics, Inc. · 2002
- This deviceK030090 H2 Heated HumidifierRespironics, Inc. · 2003
- Descendant · cites it directly · 2 of its ownK042184 Goodknight H20, Model M-114600-00Mallinckrodt Developpement France · 2005
- Descendant · 2 generations on · 1 of its ownK080439 Sandman Info Without Humidifier/ Sandman Auto Without Humidifier…Mallinckrodt Developpement France · 2008
- Descendant · 3 generations on · 0 of its ownK082237 Puritan Bennett, Sandman Duo and Sandman Duo STMallinckrodt Developpement France · 2008
Most influential descendants
Showing 3 of 3 · See all- K042184Goodknight H20, Model M-114600-00Mallinckrodt Developpement France · 2005 · cites it directly2descendants
- K080439Sandman Info Without Humidifier/ Sandman Auto Without Humidifier, Model…Mallinckrodt Developpement France · 2008 · 2 generations on1descendant
- K082237Puritan Bennett, Sandman Duo and Sandman Duo STMallinckrodt Developpement France · 2008 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K915460 | Heated Respiratory Humidifier HC100 | Fisher & Paykel Electronics, Ltd. | 1993 | — |
| −1 | K012633 | Respironics Heated Humidifier | Respironics, Inc. | 2002 | — |
| 0 (this device) | K030090 | H2 Heated Humidifier | Respironics, Inc. | 2003 | — |
| +1 | K042184 | Goodknight H20, Model M-114600-00 | Mallinckrodt Developpement France | 2005 | — |
| +2 | K080439 | Sandman Info Without Humidifier/ Sandman Auto Without Humidifier, Model… | Mallinckrodt Developpement France | 2008 | — |
| +3 | K082237 | Puritan Bennett, Sandman Duo and Sandman Duo ST | Mallinckrodt Developpement France | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2008 | 2 | 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 |
|---|---|---|---|
| * | K012633 | Respironics Heated HumidifierSummary page 1…BTT - Humidifier, Respiratory Gas, (Direct Patient Interface) Predicate Devices Respironics Heated Humidifier (K012633) Fisher & Paykel HCIOO Heated Humidifier (K915460) Reason f… | 2002 |
| * | K915460 | Heated Respiratory Humidifier HC100Summary page 1…es Respironics Heated Humidifier (K012633) Fisher & Paykel HCIOO Heated Humidifier (K915460) Reason for submission Additional or expanded indications SubstantiaI Equivale… | 1993 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K042184 | Goodknight H20, Model M-114600-00 | 2005 | 2 |
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 9.1 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K042184 (Mallinckrodt Developpement France, 2005) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K012633.
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 Respironics H2 Heated Humidifier is an accessory for positive pressure ventilation systems to provide moisture to the patient circuit.
It is intended for use with adult patients (> 30 kg), in the home or hospital/institutional environment, who use mask-applied positive pressure ventilation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030090 · printed Nov 5, 2026
Cite this page
510(k) Report. “K030090: H2 Heated Humidifier.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K030090
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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