510(k) · Cleared
ClearedRespiratory Humidifer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fisher & Paykel Healthcare, Ltd. · BTT Humidifier, Respiratory Gas, (Direct Patient Interface)
Cleared on Mar 30, 2012 as substantially equivalent to K073706 (Fisher & Paykel Healthcare, Ltd., 2008) after a 452-day review. Its family tree reaches back 6 generations to 1992. 2 later devices descend from it.
- Decided
- Mar 30, 2012
- Review
- 452 days
- Class
- Class II
- Product code
- BTT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K913368 (1992). 10 ancestors in all, the oldest K902506 (1991). 2 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK913368 Models MR700/MR720/MR730 Dual Servo Resp Humid AccFisher & Paykel Electronics, Ltd. · 1992
- 5 generations backK953392 HC500 Servo-Controlled Heated Respiratory Humidifier (& Accessories)Fisher & Paykel Electronics, Ltd. · 1996
- 4 generations backK983112 Respiratory Humidifier, Model # MR850Fisher & Paykel Healthcare, Ltd. · 1998 · Recalled
- 3 generations backK020332 Respiratory Humidifier, Model MR850Fisher & Paykel Healthcare, Ltd. · 2003 · Recalled
- 2 generations backK033710 MR850 Respiratory Humidifier, Model MR850JHUFisher & Paykel Healthcare, Ltd. · 2004
- 1 generation backK073706 Respiratory Humidifier, Model MR850Fisher & Paykel Healthcare, Ltd. · 2008
- This deviceK110019 Respiratory HumidiferFisher & Paykel Healthcare, Ltd. · 2012
- Descendant · cites it directly · 1 of its ownK220703 F&P 950 Respiratory HumidifierFisher & Paykel Healthcare · 2023
- Descendant · 2 generations on · 0 of its ownK233821 F&P Optiflow Oxygen Kit (AA451J)Fisher & Paykel Healthcare, Ltd. · 2024
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K913368 | Models MR700/MR720/MR730 Dual Servo Resp Humid Acc | Fisher & Paykel Electronics, Ltd. | 1992 | — |
| −5 | K953392 | HC500 Servo-Controlled Heated Respiratory Humidifier (& Accessories) | Fisher & Paykel Electronics, Ltd. | 1996 | — |
| −4 | K983112 | Respiratory Humidifier, Model # MR850 | Fisher & Paykel Healthcare, Ltd. | 1998 | 5 |
| −3 | K020332 | Respiratory Humidifier, Model MR850 | Fisher & Paykel Healthcare, Ltd. | 2003 | 1 |
| −2 | K033710 | MR850 Respiratory Humidifier, Model MR850JHU | Fisher & Paykel Healthcare, Ltd. | 2004 | — |
| −1 | K073706 | Respiratory Humidifier, Model MR850 | Fisher & Paykel Healthcare, Ltd. | 2008 | — |
| 0 (this device) | K110019 | Respiratory Humidifer | Fisher & Paykel Healthcare, Ltd. | 2012 | — |
| +1 | K220703 | F&P 950 Respiratory Humidifier | Fisher & Paykel Healthcare | 2023 | — |
| +2 | K233821 | F&P Optiflow Oxygen Kit (AA451J) | Fisher & Paykel Healthcare, Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K073706 | Respiratory Humidifier, Model MR850Summary page 1…e Respiratory Gas Humidifier 11 (21 CFR § 868.5450), product code Bfl Predicate device K073706 MR850 Respiratory Humidifier Fisher & Paykel Healthcaare MR850 Respiratory Humidifier… | 2008 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K220703 | F&P 950 Respiratory Humidifier | 2023 | 1 |
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 20 years and passes through 2 companies; a new generation was cleared every 4.0 years on median.
- 2 of the 10 ancestors have a recall of any class.
- Of its descendants, K220703 (Fisher & Paykel Healthcare, 2023) has gone furthest, with 1 descendant of its own.
- 10 other devices also cite its predicate K073706.
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. 2012, 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 Fisher & Paykel Healthcare MR850 humidifier is intended to be used to warm and add
humidity to gases delivered to patients requiring mechanical ventilation or positive pressure
breathing assistance or general medical gases.
The heated-wire breathing circuits are intended as conduits of breathing gas for ventilation of
patients, and to maintain the temperature of humidified inspired gas, to reduce condensation.
They are accessories for the Fisher & Paykel Healthcare MR850 Respiratory Gas Humidifier.
The RT130 is used for flow rates between 0.3 and 4 L/min, and the RT131 is for flow rates
greater than 4 L/min, for neonatal patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110019 · printed Nov 4, 2026
Cite this page
510(k) Report. “K110019: Respiratory Humidifer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K110019
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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