510(k) · Cleared
ClearedHC500 Servo-Controlled Heated Respiratory Humidifier (& Accessories)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fisher & Paykel Electronics, Ltd. · BTT Humidifier, Respiratory Gas, (Direct Patient Interface)
Cleared on Mar 12, 1996 as substantially equivalent to K913368 (Fisher & Paykel Electronics, Ltd., 1992) and 1 other predicate after a 237-day review. Its family tree reaches back 1 generation to 1992. 4 of the 77 devices in its family, counting itself, have a Class I recall. 74 later devices descend from it.
- Decided
- Mar 12, 1996
- Review
- 237 days
- Class
- Class II
- Product code
- BTT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K913368 (1992). 2 ancestors in all. 74 later devices descend from it, 2 citing it directly. 4 of the 77 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK913368 Models MR700/MR720/MR730 Dual Servo Resp Humid AccFisher & Paykel Electronics, Ltd. · 1992
- This deviceK953392 HC500 Servo-Controlled Heated Respiratory Humidifier (& Accessories)Fisher & Paykel Electronics, Ltd. · 1996
- Descendant · cites it directly · 73 of its ownK983112 Respiratory Humidifier, Model # MR850Fisher & Paykel Healthcare, Ltd. · 1998 · Recalled
- Descendant · 2 generations on · 65 of its ownK020332 Respiratory Humidifier, Model MR850Fisher & Paykel Healthcare, Ltd. · 2003 · Recalled
- Descendant · 3 generations on · 54 of its ownK033710 MR850 Respiratory Humidifier, Model MR850JHUFisher & Paykel Healthcare, Ltd. · 2004
- Descendant · 4 generations on · 47 of its ownK073706 Respiratory Humidifier, Model MR850Fisher & Paykel Healthcare, Ltd. · 2008
- Descendant · 5 generations on · 30 of its ownK092846 Airvo Series HumidifiersFisher & Paykel Healthcare, Ltd. · 2010
Showing 5 of 74 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 74 · See all- K983112Respiratory Humidifier, Model # MR850Fisher & Paykel Healthcare, Ltd. · 1998 · cites it directly73descendants
- K020332Respiratory Humidifier, Model MR850Fisher & Paykel Healthcare, Ltd. · 2003 · 2 generations on65descendants
- K033710MR850 Respiratory Humidifier, Model MR850JHUFisher & Paykel Healthcare, Ltd. · 2004 · 3 generations on54descendants
- K073706Respiratory Humidifier, Model MR850Fisher & Paykel Healthcare, Ltd. · 2008 · 4 generations on47descendants
- K092846Airvo Series HumidifiersFisher & Paykel Healthcare, Ltd. · 2010 · 5 generations on30descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K913368 | Models MR700/MR720/MR730 Dual Servo Resp Humid Acc | Fisher & Paykel Electronics, Ltd. | 1992 | — |
| 0 (this device) | K953392 | HC500 Servo-Controlled Heated Respiratory Humidifier (& Accessories) | Fisher & Paykel Electronics, Ltd. | 1996 | — |
| +1 | K983112 | Respiratory Humidifier, Model # MR850 | Fisher & Paykel Healthcare, Ltd. | 1998 | 5 |
| +2 | K020332 | Respiratory Humidifier, Model MR850 | Fisher & Paykel Healthcare, Ltd. | 2003 | 1 |
| +3 | K033710 | MR850 Respiratory Humidifier, Model MR850JHU | Fisher & Paykel Healthcare, Ltd. | 2004 | — |
| +4 | K073706 | Respiratory Humidifier, Model MR850 | Fisher & Paykel Healthcare, Ltd. | 2008 | — |
| +5 | K092846 | Airvo Series Humidifiers | Fisher & Paykel Healthcare, Ltd. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2000 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2010 | 4 | 0 |
| 2011 | 2 | 0 |
| 2012 | 3 | 0 |
| 2013 | 4 | 0 |
| 2014 | 5 | 1 |
| 2015 | 2 | 0 |
| 2016 | 4 | 1 |
| 2017 | 3 | 1 |
| 2018 | 3 | 1 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 3 | 0 |
| 2022 | 3 | 0 |
| 2023 | 7 | 0 |
| 2024 | 9 | 0 |
| 2025 | 6 | 0 |
| 2026 | 4 | 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.
4 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? (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 |
|---|---|---|---|
| * | K913368 | Models MR700/MR720/MR730 Dual Servo Resp Humid AccSummary page 1…umidifier, Respiratory Gas, Direct Patient Interface - 73 BTT Anesthesiology Devices, 21 CFR §868.5450 Predicate Devices: Fisher & Paykel, MR730 Respiratory Humidifier, K913368 Fisher & Paykel, MR410 Respiratory Humidifier, K913367 This summary of 510(k) safety and effectiveness information is being subm… | 1992 |
| * | K913367 | Models MR410 & MR480 Respiratory Humidifier/AccessSummary page 1…73 BTT Anesthesiology Devices, 21 CFR §868.5450 Predicate Devices: Fisher & Paykel, MR730 Respiratory Humidifier, K913368 Fisher & Paykel, MR410 Respiratory Humidifier, K913367 This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990… | 1992 |
What descends from it? (74)
See all 742 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (4 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.
- K151303AirLife Infant Heated Wire CircuitCare Fusion · 2016 · 3 generations on · ◆ in the 2016 descendants bar of FIG. 12 Class I recalls
- K131912Conchatherm Neptune Heated Humidifier, Comfort Flo Humidification System, Conchasmart ColumnTeleflex, Inc. · 2014 · 5 generations on · ◆ in the 2014 descendants bar of FIG. 12 Class I recalls
- K173280Neonatal ConchaSmart Breathing CircuitsTeleflexmedical, Inc. · 2018 · 5 generations on · ◆ in the 2018 descendants bar of FIG. 11 Class I recall
- K162242Comfort Flo Humidification SystemTeleflexmedical, Inc. · 2017 · 6 generations on · ◆ in the 2017 descendants bar of FIG. 12 Class I recalls
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 intended use of the HC500 is to provide therapeutic levels of heat and humidity to a patient's inspired respiratory gases, when using an artificial ventilation system. This includes use with systems such as portable volume ventilation systems, pressure support ventilation and continuous positive airway pressure (CPAP) devices. These systems may bypass the patient airway (using an endotracheal tube) or use mask ventilation. Providing heat and…
Read the full statement (149 words)
The intended use of the HC500 is to provide therapeutic levels of heat and humidity to a patient's inspired respiratory gases, when using an artificial ventilation system. This includes use with systems such as portable volume ventilation systems, pressure support ventilation and continuous positive airway pressure (CPAP) devices. These systems may bypass the patient airway (using an endotracheal tube) or use mask ventilation. Providing heat and humidification to these gases counteracts the effects of bypassing the nose, pharynx and trachea, where this function would normally be carried out by the body. Addition of heat and humidity to the supply of cold and dry respiratory gases provided through mask ventilation is similarly beneficial to prevent drying of the patient airways. The HCS500 is primarily intended for a home-use situation, typically for patients requiring long-term respiratory assistance of a non-critical nature (ie not requiring hospital or intensive care levels of attention).
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/K953392 · printed Nov 6, 2026
Cite this page
510(k) Report. “K953392: HC500 Servo-Controlled Heated Respiratory Humidifier (& Accessories).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K953392
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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