510(k) · Cleared
ClearedRespiratory Humidifier, Model MR850
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 31, 2008 as substantially equivalent to K033710 (Fisher & Paykel Healthcare, Ltd., 2004) after a 91-day review. Its family tree reaches back 5 generations to 1992. 47 later devices descend from it.
- Decided
- Mar 31, 2008
- Review
- 91 days
- Class
- Class II
- Product code
- BTT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K913368 (1992). 9 ancestors in all, the oldest K902506 (1991). 47 later devices descend from it, 11 citing it directly.
- Root · 5 generations backK913368 Models MR700/MR720/MR730 Dual Servo Resp Humid AccFisher & Paykel Electronics, Ltd. · 1992
- 4 generations backK953392 HC500 Servo-Controlled Heated Respiratory Humidifier (& Accessories)Fisher & Paykel Electronics, Ltd. · 1996
- 3 generations backK983112 Respiratory Humidifier, Model # MR850Fisher & Paykel Healthcare, Ltd. · 1998 · Recalled
- 2 generations backK020332 Respiratory Humidifier, Model MR850Fisher & Paykel Healthcare, Ltd. · 2003 · Recalled
- 1 generation backK033710 MR850 Respiratory Humidifier, Model MR850JHUFisher & Paykel Healthcare, Ltd. · 2004
- This deviceK073706 Respiratory Humidifier, Model MR850Fisher & Paykel Healthcare, Ltd. · 2008
- Descendant · cites it directly · 30 of its ownK092846 Airvo Series HumidifiersFisher & Paykel Healthcare, Ltd. · 2010
- Descendant · cites it directly · 25 of its ownK121975 Airvo Humidifier Myairo HumidifierFisher & Paykel Healthcare, Ltd. · 2013
- Descendant · cites it directly · 24 of its ownK131895 Airvo 2 Humidifier, Myairvo 2 HumidifierFisher & Paykel Healthcare, Ltd. · 2013 · Recalled
- Descendant · 2 generations on · 15 of its ownK162553 AirSpiral Heated Breathing TubeFisher & Paykel Healthcare · 2018
- Descendant · cites it directly · 4 of its ownK100554 Respiratory Humidifier , Heated Delivery System, Adaptor, Models…Fisher & Paykel Healthcare, Ltd. · 2010
Showing 5 of 47 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 47 · See all- K092846Airvo Series HumidifiersFisher & Paykel Healthcare, Ltd. · 2010 · cites it directly30descendants
- K121975Airvo Humidifier Myairo HumidifierFisher & Paykel Healthcare, Ltd. · 2013 · cites it directly25descendants
- K131895Airvo 2 Humidifier, Myairvo 2 HumidifierFisher & Paykel Healthcare, Ltd. · 2013 · cites it directly24descendants
- K162553AirSpiral Heated Breathing TubeFisher & Paykel Healthcare · 2018 · 2 generations on15descendants
- K100554Respiratory Humidifier , Heated Delivery System, Adaptor, Models MR880, RT241, 900MR441Fisher & Paykel Healthcare, Ltd. · 2010 · cites it directly4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K913368 | Models MR700/MR720/MR730 Dual Servo Resp Humid Acc | Fisher & Paykel Electronics, Ltd. | 1992 | — |
| −4 | K953392 | HC500 Servo-Controlled Heated Respiratory Humidifier (& Accessories) | Fisher & Paykel Electronics, Ltd. | 1996 | — |
| −3 | K983112 | Respiratory Humidifier, Model # MR850 | Fisher & Paykel Healthcare, Ltd. | 1998 | 5 |
| −2 | K020332 | Respiratory Humidifier, Model MR850 | Fisher & Paykel Healthcare, Ltd. | 2003 | 1 |
| −1 | K033710 | MR850 Respiratory Humidifier, Model MR850JHU | Fisher & Paykel Healthcare, Ltd. | 2004 | — |
| 0 (this device) | K073706 | Respiratory Humidifier, Model MR850 | Fisher & Paykel Healthcare, Ltd. | 2008 | — |
| +1 | K092846 | Airvo Series Humidifiers | Fisher & Paykel Healthcare, Ltd. | 2010 | — |
| +1 | K121975 | Airvo Humidifier Myairo Humidifier | Fisher & Paykel Healthcare, Ltd. | 2013 | — |
| +1 | K131895 | Airvo 2 Humidifier, Myairvo 2 Humidifier | Fisher & Paykel Healthcare, Ltd. | 2013 | 2 |
| +2 | K162553 | AirSpiral Heated Breathing Tube | Fisher & Paykel Healthcare | 2018 | — |
| +1 | K100554 | Respiratory Humidifier , Heated Delivery System, Adaptor, Models MR880, RT241… | Fisher & Paykel Healthcare, Ltd. | 2010 | — |
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 |
|---|---|---|
| 2010 | 4 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 4 | 0 |
| 2014 | 3 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 3 | 0 |
| 2023 | 6 | 0 |
| 2024 | 8 | 0 |
| 2025 | 6 | 0 |
| 2026 | 3 | 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 |
|---|---|---|---|
| * | K033710 | MR850 Respiratory Humidifier, Model MR850JHUSummary page 1…as Humidifier Classification name Respiratory Gas Humidifier 11 (21 CFR § 868.5450), product code BTT Predicate device K03371 0 Fisher & Paykel Healthcare MR850 Respiratory Humidifier Fisher& Paykel Healthcare MR850 Respiratory Humidifi… | 2004 |
What descends from it? (47)
See all 4711 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K092846 | Airvo Series Humidifiers | 2010 | 30 |
| K121975 | Airvo Humidifier Myairo Humidifier | 2013 | 25 |
| K131895 | Airvo 2 Humidifier, Myairvo 2 Humidifier | 2013 | 24 |
| K100554 | Respiratory Humidifier , Heated Delivery System, Adaptor, Models MR880, RT241, 900MR441 | 2010 | 4 |
| K110019 | Respiratory Humidifer | 2012 | 2 |
| K102618 | Ventstar Heated, Infinity ID Breathing Circuit Heated | 2010 | 2 |
| K092256 | Thera- Heat Heated Humidifier, Model RC70000, RC70072, RC70075, RC70077, RC70012 | 2010 | 2 |
| K161314 | Flexicare FL-9000U Respiratory Humidifier Base | 2016 | 1 |
| K122705 | Humicare D900 | 2013 | 1 |
| K222351 | inspired™ VHB20 Heated Humidifier | 2022 | 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 16 years and passes through 2 companies; a new generation was cleared every 4.0 years on median.
- 2 of the 9 ancestors have a recall of any class.
- Of its descendants, K092846 (Fisher & Paykel Healthcare, Ltd., 2010) has gone furthest, with 30 descendants of its own.
- 5 other devices also cite its predicate K033710.
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. 2008, 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/K073706 · printed Nov 4, 2026
Cite this page
510(k) Report. “K073706: Respiratory Humidifier, Model MR850.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073706
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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