510(k) · Cleared
Recalled · 2008Respiratory 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 Nov 10, 1998 as substantially equivalent to K913368 (Fisher & Paykel Electronics, Ltd., 1992) and 3 other predicates after a 67-day review. Its family tree reaches back 2 generations to 1992. 4 of the 79 devices in its family, counting itself, have a Class I recall. 73 later devices descend from it. It has been recalled 5 times.
- Decided
- Nov 10, 1998
- Review
- 67 days
- Class
- Class II
- Product code
- BTT
- Recalls
- 5
- Predicates
- 4
Its longest line of descent runs back 2 generations to K913368 (1992). 5 ancestors in all, the oldest K902506 (1991). 73 later devices descend from it, 9 citing it directly. 4 of the 79 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK913368 Models MR700/MR720/MR730 Dual Servo Resp Humid AccFisher & Paykel Electronics, Ltd. · 1992
- 1 generation backK953392 HC500 Servo-Controlled Heated Respiratory Humidifier (& Accessories)Fisher & Paykel Electronics, Ltd. · 1996
- This deviceK983112 Respiratory Humidifier, Model # MR850Fisher & Paykel Healthcare, Ltd. · 1998
- Descendant · cites it directly · 65 of its ownK020332 Respiratory Humidifier, Model MR850Fisher & Paykel Healthcare, Ltd. · 2003 · Recalled
- Descendant · 2 generations on · 54 of its ownK033710 MR850 Respiratory Humidifier, Model MR850JHUFisher & Paykel Healthcare, Ltd. · 2004
- Descendant · 3 generations on · 47 of its ownK073706 Respiratory Humidifier, Model MR850Fisher & Paykel Healthcare, Ltd. · 2008
- Descendant · 4 generations on · 30 of its ownK092846 Airvo Series HumidifiersFisher & Paykel Healthcare, Ltd. · 2010
- Descendant · 4 generations on · 25 of its ownK121975 Airvo Humidifier Myairo HumidifierFisher & Paykel Healthcare, Ltd. · 2013
Showing 5 of 73 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 73 · See all- K020332Respiratory Humidifier, Model MR850Fisher & Paykel Healthcare, Ltd. · 2003 · cites it directly65descendants
- K033710MR850 Respiratory Humidifier, Model MR850JHUFisher & Paykel Healthcare, Ltd. · 2004 · 2 generations on54descendants
- K073706Respiratory Humidifier, Model MR850Fisher & Paykel Healthcare, Ltd. · 2008 · 3 generations on47descendants
- K092846Airvo Series HumidifiersFisher & Paykel Healthcare, Ltd. · 2010 · 4 generations on30descendants
- K121975Airvo Humidifier Myairo HumidifierFisher & Paykel Healthcare, Ltd. · 2013 · 4 generations on25descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K913368 | Models MR700/MR720/MR730 Dual Servo Resp Humid Acc | Fisher & Paykel Electronics, Ltd. | 1992 | — |
| −1 | K953392 | HC500 Servo-Controlled Heated Respiratory Humidifier (& Accessories) | Fisher & Paykel Electronics, Ltd. | 1996 | — |
| 0 (this device) | K983112 | Respiratory Humidifier, Model # MR850 | Fisher & Paykel Healthcare, Ltd. | 1998 | — |
| +1 | K020332 | Respiratory Humidifier, Model MR850 | Fisher & Paykel Healthcare, Ltd. | 2003 | 1 |
| +2 | K033710 | MR850 Respiratory Humidifier, Model MR850JHU | Fisher & Paykel Healthcare, Ltd. | 2004 | — |
| +3 | K073706 | Respiratory Humidifier, Model MR850 | Fisher & Paykel Healthcare, Ltd. | 2008 | — |
| +4 | K092846 | Airvo Series Humidifiers | Fisher & Paykel Healthcare, Ltd. | 2010 | — |
| +4 | K121975 | Airvo Humidifier Myairo Humidifier | Fisher & Paykel Healthcare, Ltd. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (4)
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…espiratory Gas (Direct Patient Interface) - 73 BTT Anesthesiology Devices, 21 CFR §868.5450 (Class Il) Predicate Devices: Fisher & Paykel, MR730 Respiratory Humidifier, K913368 Fisher & Paykel, HC500 Respiratory Humidifier, K953392 Fisher & Paykel, MR290 Humidification Chamber, K934140 Puritan-Bennett, 72… | 1992 |
| * | K953392 | HC500 Servo-Controlled Heated Respiratory Humidifier (& Accessories)Summary page 1…thesiology Devices, 21 CFR §868.5450 (Class Il) Predicate Devices: Fisher & Paykel, MR730 Respiratory Humidifier, K913368 Fisher & Paykel, HC500 Respiratory Humidifier, K953392 Fisher & Paykel, MR290 Humidification Chamber, K934140 Puritan-Bennett, 7200 Microprocessor Ventilator, K902506 This summary of… | 1996 |
| * | K934140 | MR290 Humidification Chamber Single UseSummary page 1…ate Devices: Fisher & Paykel, MR730 Respiratory Humidifier, K913368 Fisher & Paykel, HC500 Respiratory Humidifier, K953392 Fisher & Paykel, MR290 Humidification Chamber, K934140 Puritan-Bennett, 7200 Microprocessor Ventilator, K902506 This summary of 510(k) safety and effectiveness information is being su… | 1994 |
| * | K902506 | 7200AE Microprocessor Ventilator W/Enhanced Hard.Summary page 1…r, K913368 Fisher & Paykel, HC500 Respiratory Humidifier, K953392 Fisher & Paykel, MR290 Humidification Chamber, K934140 Puritan-Bennett, 7200 Microprocessor Ventilator, K902506 This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR §80… | 1991 |
What descends from it? (73)
See all 739 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K020332 | Respiratory Humidifier, Model MR850 | 2003 | 65 |
| K110398 | Respironics Disposable Heated Wire Circuits | 2011 | 3 |
| K102618 | Ventstar Heated, Infinity ID Breathing Circuit Heated | 2010 | 2 |
| K152029 | Hamilton-H900, Hamilton-BC8022, Hamilton-BC4022, Hamilton-BC8010, Hamilton-BC4010 | 2016 | 1 |
| K122705 | Humicare D900 | 2013 | 1 |
| K223684 | F&P 820 Humidification System | 2023 | 0 |
| K170378 | AirLife Adult Heated Wire BiPAP/NIV Circuit | 2017 | 0 |
| K993773 | Humid-Heat | 2000 | 0 |
| K993268 | Mallinckrodt Dar Heated Wire Breathing Circuit | 2000 | 0 |
Has anything in its family been recalled? (4 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 22, 2008 | Not classified | Z-0414-2009 | Process change control | The recall was initiated because certain lot dates of the RT240 Adult Breathing Circuit Kits manufactured on or before June 27, 2008 include a heated breathing circuit that may be more susceptible to damage when used in excess of the… |
| Dec 20, 2005 | Not classified | Z-0695-06 | Other | Risk of fire. The manufacturing process may have the potential to damage the insulation of the heater wire in circuits within the specified lot range. This may lead to a potential risk of fire. |
| Dec 20, 2005 | Not classified | Z-0696-06 | Other | Risk of fire. The manufacturing process may have the potential to damage the insulation of the heater wire in circuits within the specified lot range. This may lead to a potential risk of fire. |
| Dec 20, 2005 | Not classified | Z-0694-06 | Other | Risk of fire. The manufacturing process may have the potential to damage the insulation of the heater wire in circuits within the specified lot range. This may lead to a potential risk of fire. |
| Dec 20, 2005 | Not classified | Z-0697-06 | Other | Risk of fire. The manufacturing process may have the potential to damage the insulation of the heater wire in circuits within the specified lot range. This may lead to a potential risk of fire. |
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 · 2 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 · 4 generations on · ◆ in the 2014 descendants bar of FIG. 12 Class I recalls
- K173280Neonatal ConchaSmart Breathing CircuitsTeleflexmedical, Inc. · 2018 · 4 generations on · ◆ in the 2018 descendants bar of FIG. 11 Class I recall
- K162242Comfort Flo Humidification SystemTeleflexmedical, Inc. · 2017 · 5 generations on · ◆ in the 2017 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 6 years and passes through 2 companies; a new generation was cleared every 4.2 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K020332 (Fisher & Paykel Healthcare, Ltd., 2003) has gone furthest, with 65 descendants of its own.
- 6 other devices also cite its predicate K913368.
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 Fisher & Paykel Healthcare MR850 Humidifier is a Respiratory Gas Humidifier as per 73 BTT, 21 CFR §868.5450. It is intended to add moisture to and warm breathing gases for administration to a patient. The MR850 is intended to be used to warm and add humidity to gases delivered to patients requiring mechanical ventilation, positive pressure breathing assistance or general medical gases. Gases available for medical use do not contain sufficient…
Read the full statement (122 words)
The Fisher & Paykel Healthcare MR850 Humidifier is a Respiratory Gas Humidifier as per 73 BTT, 21 CFR §868.5450. It is intended to add moisture to and warm breathing gases for administration to a patient.
The MR850 is intended to be used to warm and add humidity to gases delivered to patients requiring mechanical ventilation, positive pressure breathing assistance or general medical gases.
Gases available for medical use do not contain sufficient moisture and may damage or irritate the respiratory tract, or desiccate secretions of patients whose supraglottic airways have been bypassed. Heat is used to increase the water output of the humidifier. Heated breathing tubes are also utilized in order to increase operating efficiency and reduce excessive water and heat loss.
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/K983112 · printed Nov 5, 2026
Cite this page
510(k) Report. “K983112: Respiratory Humidifier, Model # MR850.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K983112
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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