510(k) · Cleared
ClearedMR810 System, 900MR810 Adult Single Limb Circuit, 900MR810E Adult Dual Limb Circuit
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 5, 2015 as substantially equivalent to K131957 (Fisher & Paykel Healthcare, Ltd., 2013) after a 73-day review. Its family tree reaches back 8 generations to 1992. 1 later device descends from it.
- Decided
- Mar 5, 2015
- Review
- 73 days
- Class
- Class II
- Product code
- BTT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K913368 (1992). 12 ancestors in all, the oldest K902506 (1991). 1 later device descends from it, 1 citing it directly.
- Root · 8 generations backK913368 Models MR700/MR720/MR730 Dual Servo Resp Humid AccFisher & Paykel Electronics, Ltd. · 1992
- 7 generations backK953392 HC500 Servo-Controlled Heated Respiratory Humidifier (& Accessories)Fisher & Paykel Electronics, Ltd. · 1996
- 6 generations backK983112 Respiratory Humidifier, Model # MR850Fisher & Paykel Healthcare, Ltd. · 1998 · Recalled
- 5 generations backK020332 Respiratory Humidifier, Model MR850Fisher & Paykel Healthcare, Ltd. · 2003 · Recalled
- 4 generations backK033710 MR850 Respiratory Humidifier, Model MR850JHUFisher & Paykel Healthcare, Ltd. · 2004
- 3 generations backK073706 Respiratory Humidifier, Model MR850Fisher & Paykel Healthcare, Ltd. · 2008
- 2 generations backK100554 Respiratory Humidifier , Heated Delivery System, Adaptor, Models…Fisher & Paykel Healthcare, Ltd. · 2010
- 1 generation backK131957 MR810RESPIRATORY Humidifier, 900MR810 Adult Single Limb Circuit…Fisher & Paykel Healthcare, Ltd. · 2013
- This deviceK143646 MR810 System, 900MR810 Adult Single Limb Circuit, 900MR810E Adult…Fisher & Paykel Healthcare, Ltd. · 2015
- Descendant · cites it directly · 0 of its ownK223684 F&P 820 Humidification SystemFisher & Paykel Healthcare, Ltd. · 2023
Most influential descendants
Showing 1 of 1 · See all- K223684F&P 820 Humidification SystemFisher & Paykel Healthcare, Ltd. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K913368 | Models MR700/MR720/MR730 Dual Servo Resp Humid Acc | Fisher & Paykel Electronics, Ltd. | 1992 | — |
| −7 | K953392 | HC500 Servo-Controlled Heated Respiratory Humidifier (& Accessories) | Fisher & Paykel Electronics, Ltd. | 1996 | — |
| −6 | K983112 | Respiratory Humidifier, Model # MR850 | Fisher & Paykel Healthcare, Ltd. | 1998 | 5 |
| −5 | K020332 | Respiratory Humidifier, Model MR850 | Fisher & Paykel Healthcare, Ltd. | 2003 | 1 |
| −4 | K033710 | MR850 Respiratory Humidifier, Model MR850JHU | Fisher & Paykel Healthcare, Ltd. | 2004 | — |
| −3 | K073706 | Respiratory Humidifier, Model MR850 | Fisher & Paykel Healthcare, Ltd. | 2008 | — |
| −2 | K100554 | Respiratory Humidifier , Heated Delivery System, Adaptor, Models MR880, RT241… | Fisher & Paykel Healthcare, Ltd. | 2010 | — |
| −1 | K131957 | MR810RESPIRATORY Humidifier, 900MR810 Adult Single Limb Circuit, 900MR810E… | Fisher & Paykel Healthcare, Ltd. | 2013 | — |
| 0 (this device) | K143646 | MR810 System, 900MR810 Adult Single Limb Circuit, 900MR810E Adult Dual Limb… | Fisher & Paykel Healthcare, Ltd. | 2015 | — |
| +1 | K223684 | F&P 820 Humidification System | Fisher & Paykel Healthcare, Ltd. | 2023 | — |
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 |
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 |
|---|---|---|---|
| * | K131957 | MR810RESPIRATORY Humidifier, 900MR810 Adult Single Limb Circuit, 900MR810E Adult Dual…Summary page 4…as humidifier Classification name Respiratory gas humidifier II (21 CFR §868.5450), product code BTT Predicate device K131957 MR810 System Reason for submission Expanded indications Fisher & Paykel Healthcare MR810 Syst… | 2013 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K223684 | F&P 820 Humidification System | 2023 | 0 |
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 23 years and passes through 2 companies; a new generation was cleared every 3.5 years on median.
- 2 of the 12 ancestors have a recall of any class.
- Of its descendants, K223684 (Fisher & Paykel Healthcare, Ltd., 2023) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K131957.
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. 2015, 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 MR810 System is intended to provide therapeutic levels of heat and humidity to a patient’s inspired respiratory gases, when using a continuous or intermittent ventilator system or a continuous gas flow system. The MR810 System is intended for both non-invasive and invasive therapies. Addition of heat and humidity to the supply of cold and dry respiratory gases provided through non-invasive or invasive ventilation is beneficial to…
Read the full statement (116 words)
The Fisher & Paykel MR810 System is intended to provide therapeutic levels of heat and humidity to a patient’s inspired respiratory gases, when using a continuous or intermittent ventilator system or a continuous gas flow system.
The MR810 System is intended for both non-invasive and invasive therapies. Addition of heat and humidity to the supply of cold and dry respiratory gases provided through non-invasive or invasive ventilation is beneficial to prevent drying of the patient airways.
The MR810 System is for use for adult and pediatric patients requiring a flow range ≥5 L/min.
The MR810 System is designed for use in hospitals, long term care facilities and homes under the prescription of a qualified medical professional.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K143646 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143646: MR810 System, 900MR810 Adult Single Limb Circuit, 900MR810E Adult Dual Limb Circuit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143646
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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