510(k) · Cleared
ClearedRespironics 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 Feb 28, 2002 as substantially equivalent to K915460 (Fisher & Paykel Electronics, Ltd., 1993) after a 199-day review. Its family tree reaches back 1 generation to 1993. 5 later devices descend from it.
- Decided
- Feb 28, 2002
- Review
- 199 days
- Class
- Class II
- Product code
- BTT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K915460 (1993). 5 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK915460 Heated Respiratory Humidifier HC100Fisher & Paykel Electronics, Ltd. · 1993
- This deviceK012633 Respironics Heated HumidifierRespironics, Inc. · 2002
- Descendant · cites it directly · 3 of its ownK030090 H2 Heated HumidifierRespironics, Inc. · 2003
- Descendant · 2 generations on · 2 of its ownK042184 Goodknight H20, Model M-114600-00Mallinckrodt Developpement France · 2005
- Descendant · 3 generations on · 1 of its ownK080439 Sandman Info Without Humidifier/ Sandman Auto Without Humidifier…Mallinckrodt Developpement France · 2008
- Descendant · 4 generations on · 0 of its ownK082237 Puritan Bennett, Sandman Duo and Sandman Duo STMallinckrodt Developpement France · 2008
- Descendant · cites it directly · 0 of its ownK031176 Invacare Polaris EX Heated Humidifier, Model ISP4000Invacare Corp. · 2004
Most influential descendants
Showing 5 of 5 · See all- K030090H2 Heated HumidifierRespironics, Inc. · 2003 · cites it directly3descendants
- K042184Goodknight H20, Model M-114600-00Mallinckrodt Developpement France · 2005 · 2 generations on2descendants
- K080439Sandman Info Without Humidifier/ Sandman Auto Without Humidifier, Model…Mallinckrodt Developpement France · 2008 · 3 generations on1descendant
- K082237Puritan Bennett, Sandman Duo and Sandman Duo STMallinckrodt Developpement France · 2008 · 4 generations on0descendants
- K031176Invacare Polaris EX Heated Humidifier, Model ISP4000Invacare Corp. · 2004 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K915460 | Heated Respiratory Humidifier HC100 | Fisher & Paykel Electronics, Ltd. | 1993 | — |
| 0 (this device) | K012633 | Respironics Heated Humidifier | Respironics, Inc. | 2002 | — |
| +1 | K030090 | H2 Heated Humidifier | Respironics, Inc. | 2003 | — |
| +2 | K042184 | Goodknight H20, Model M-114600-00 | Mallinckrodt Developpement France | 2005 | — |
| +3 | K080439 | Sandman Info Without Humidifier/ Sandman Auto Without Humidifier, Model… | Mallinckrodt Developpement France | 2008 | — |
| +4 | K082237 | Puritan Bennett, Sandman Duo and Sandman Duo ST | Mallinckrodt Developpement France | 2008 | — |
| +1 | K031176 | Invacare Polaris EX Heated Humidifier, Model ISP4000 | Invacare Corp. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K915460 | Heated Respiratory Humidifier HC100Summary page 1…spironics Heated Humidifier Predicate Device(s) E%'éeos1p(i)r20ég<):s REMstar Plus CPAP System/REMstar Heated Humidifier Fisher & Paykel, HC100 Respiratory Humidifier (K915460) Reason for submission New design. This summary of 510(k) safety and effectiveness information is being submitted in accordance… | 1993 |
| * | — | REMstar Plus CPAP System/REMstar Heated Humidifier Named without a submission number |
What descends from it? (5)
2 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?
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 Heated Humidifier is an accessory for CPAP and Bi-level systems to provide moisture to
the patient circuit.
It is intended for use with adult patients, in the home or hospital/institutional environment, who use mask-
applied CPAP or Bi-level therapy for the treatment of Obstructive Sleep Apnea.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K012633 · printed Nov 6, 2026
Cite this page
510(k) Report. “K012633: Respironics 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/K012633
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026