510(k) · Cleared
ClearedHeated Respiratory Humidifier HC100
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 Jan 15, 1993 after a 408-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 117 later devices descend from it.
- Decided
- Jan 15, 1993
- Review
- 408 days
- Class
- Class II
- Product code
- BTT
- Recalls
- None
- Predicates
- 0
117 later devices descend from it, 3 citing it directly.
- This deviceK915460 Heated Respiratory Humidifier HC100Fisher & Paykel Electronics, Ltd. · 1993
- Descendant · cites it directly · 110 of its ownK973161 Cpap Humidifier (HC 200)Fisher & Paykel Electronics, Ltd. · 1998
- Descendant · 2 generations on · 98 of its ownK040941 Cpap Humidifier, Model HC234 (and Related Accessories)Fisher & Paykel Healthcare, Ltd. · 2004
- Descendant · 3 generations on · 74 of its ownK041900 HC604 Cpap HumidifierFisher & Paykel Healthcare, Ltd. · 2004
- Descendant · 4 generations on · 33 of its ownK082605 Vpap Auto with Humidaire 3IResmed, Ltd. · 2009
- Descendant · 5 generations on · 31 of its ownK091947 S8 Aspen with H4I PlusResmed, Ltd. · 2009
Showing 5 of 117 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 117 · See all- K973161Cpap Humidifier (HC 200)Fisher & Paykel Electronics, Ltd. · 1998 · cites it directly110descendants
- K040941Cpap Humidifier, Model HC234 (and Related Accessories)Fisher & Paykel Healthcare, Ltd. · 2004 · 2 generations on98descendants
- K041900HC604 Cpap HumidifierFisher & Paykel Healthcare, Ltd. · 2004 · 3 generations on74descendants
- K082605Vpap Auto with Humidaire 3IResmed, Ltd. · 2009 · 4 generations on33descendants
- K091947S8 Aspen with H4I PlusResmed, Ltd. · 2009 · 5 generations on31descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K915460 | Heated Respiratory Humidifier HC100 | Fisher & Paykel Electronics, Ltd. | 1993 | — |
| +1 | K973161 | Cpap Humidifier (HC 200) | Fisher & Paykel Electronics, Ltd. | 1998 | — |
| +2 | K040941 | Cpap Humidifier, Model HC234 (and Related Accessories) | Fisher & Paykel Healthcare, Ltd. | 2004 | — |
| +3 | K041900 | HC604 Cpap Humidifier | Fisher & Paykel Healthcare, Ltd. | 2004 | — |
| +4 | K082605 | Vpap Auto with Humidaire 3I | Resmed, Ltd. | 2009 | — |
| +5 | K091947 | S8 Aspen with H4I Plus | Resmed, Ltd. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 4 | 0 |
| 2005 | 3 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 4 | 0 |
| 2009 | 3 | 0 |
| 2010 | 4 | 0 |
| 2011 | 7 | 0 |
| 2012 | 8 | 0 |
| 2013 | 9 | 0 |
| 2014 | 8 | 0 |
| 2015 | 1 | 0 |
| 2016 | 5 | 0 |
| 2017 | 3 | 0 |
| 2018 | 4 | 0 |
| 2019 | 2 | 0 |
| 2020 | 5 | 0 |
| 2021 | 4 | 0 |
| 2022 | 5 | 0 |
| 2023 | 6 | 0 |
| 2024 | 12 | 0 |
| 2025 | 8 | 0 |
| 2026 | 5 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (117)
See all 1173 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?
- Of its descendants, K973161 (Fisher & Paykel Electronics, Ltd., 1998) has gone furthest, with 110 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 | — |
https://510kreport.com/device/K915460 · printed Nov 5, 2026
Cite this page
510(k) Report. “K915460: Heated Respiratory Humidifier HC100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K915460
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026