510(k) · Cleared
Recalled · 2004Respiratory 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 Jul 7, 2003 as substantially equivalent to K983112 (Fisher & Paykel Healthcare, Ltd., 1998) and 1 other predicate after a 522-day review. Its family tree reaches back 3 generations to 1992. 4 of the 73 devices in its family, counting itself, have a Class I recall. 65 later devices descend from it. It has been recalled once.
- Decided
- Jul 7, 2003
- Review
- 522 days
- Class
- Class II
- Product code
- BTT
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 3 generations to K913368 (1992). 7 ancestors in all, the oldest K902506 (1991). 65 later devices descend from it, 5 citing it directly. 4 of the 73 devices in this family, counting this one, have a Class I recall.
- Root · 3 generations backK913368 Models MR700/MR720/MR730 Dual Servo Resp Humid AccFisher & Paykel Electronics, Ltd. · 1992
- 2 generations backK953392 HC500 Servo-Controlled Heated Respiratory Humidifier (& Accessories)Fisher & Paykel Electronics, Ltd. · 1996
- 1 generation backK983112 Respiratory Humidifier, Model # MR850Fisher & Paykel Healthcare, Ltd. · 1998 · Recalled
- This deviceK020332 Respiratory Humidifier, Model MR850Fisher & Paykel Healthcare, Ltd. · 2003
- Descendant · cites it directly · 54 of its ownK033710 MR850 Respiratory Humidifier, Model MR850JHUFisher & Paykel Healthcare, Ltd. · 2004
- Descendant · 2 generations on · 47 of its ownK073706 Respiratory Humidifier, Model MR850Fisher & Paykel Healthcare, Ltd. · 2008
- Descendant · 3 generations on · 30 of its ownK092846 Airvo Series HumidifiersFisher & Paykel Healthcare, Ltd. · 2010
- Descendant · 3 generations on · 25 of its ownK121975 Airvo Humidifier Myairo HumidifierFisher & Paykel Healthcare, Ltd. · 2013
- Descendant · 3 generations on · 24 of its ownK131895 Airvo 2 Humidifier, Myairvo 2 HumidifierFisher & Paykel Healthcare, Ltd. · 2013 · Recalled
Showing 5 of 65 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 65 · See all- K033710MR850 Respiratory Humidifier, Model MR850JHUFisher & Paykel Healthcare, Ltd. · 2004 · cites it directly54descendants
- K073706Respiratory Humidifier, Model MR850Fisher & Paykel Healthcare, Ltd. · 2008 · 2 generations on47descendants
- K092846Airvo Series HumidifiersFisher & Paykel Healthcare, Ltd. · 2010 · 3 generations on30descendants
- K121975Airvo Humidifier Myairo HumidifierFisher & Paykel Healthcare, Ltd. · 2013 · 3 generations on25descendants
- K131895Airvo 2 Humidifier, Myairvo 2 HumidifierFisher & Paykel Healthcare, Ltd. · 2013 · 3 generations on24descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K913368 | Models MR700/MR720/MR730 Dual Servo Resp Humid Acc | Fisher & Paykel Electronics, Ltd. | 1992 | — |
| −2 | K953392 | HC500 Servo-Controlled Heated Respiratory Humidifier (& Accessories) | Fisher & Paykel Electronics, Ltd. | 1996 | — |
| −1 | K983112 | Respiratory Humidifier, Model # MR850 | Fisher & Paykel Healthcare, Ltd. | 1998 | 5 |
| 0 (this device) | K020332 | Respiratory Humidifier, Model MR850 | Fisher & Paykel Healthcare, Ltd. | 2003 | — |
| +1 | K033710 | MR850 Respiratory Humidifier, Model MR850JHU | Fisher & Paykel Healthcare, Ltd. | 2004 | — |
| +2 | K073706 | Respiratory Humidifier, Model MR850 | Fisher & Paykel Healthcare, Ltd. | 2008 | — |
| +3 | K092846 | Airvo Series Humidifiers | Fisher & Paykel Healthcare, Ltd. | 2010 | — |
| +3 | K121975 | Airvo Humidifier Myairo Humidifier | Fisher & Paykel Healthcare, Ltd. | 2013 | — |
| +3 | K131895 | Airvo 2 Humidifier, Myairvo 2 Humidifier | Fisher & Paykel Healthcare, Ltd. | 2013 | 2 |
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 |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2010 | 4 | 0 |
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 4 | 0 |
| 2014 | 4 | 1 |
| 2015 | 2 | 0 |
| 2016 | 4 | 1 |
| 2017 | 2 | 1 |
| 2018 | 3 | 1 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 3 | 0 |
| 2023 | 7 | 0 |
| 2024 | 8 | 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? (2)
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 |
|---|---|---|---|
| * | K983112 | Respiratory Humidifier, Model # MR850Summary page 1…umidifier Common name Respiratory Humidifier Classification name Respiratory Gas Humidifier (2 1 CFR $ 868.5450) Predicate device MR850 Respiratory Humidifier, K983 1 12 Airlife Breathing Circuit, KO00697 Description of device The MR850 Humidifier is a Respirat… | 1998 |
| * | K000697 | Modification to Airlife Heated Ventilator and Anesthesia Breathing Circuits | 2000 |
What descends from it? (65)
See all 655 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K033710 | MR850 Respiratory Humidifier, Model MR850JHU | 2004 | 54 |
| K034026 | RT 138 & RT 141 Dual-Heated Neonatal Breathing Circuits | 2005 | 12 |
| K102618 | Ventstar Heated, Infinity ID Breathing Circuit Heated | 2010 | 2 |
| K220703 | F&P 950 Respiratory Humidifier | 2023 | 1 |
| K151303 | AirLife Infant Heated Wire Circuit Class I | 2016 | 0 |
Has anything in its family been recalled? (4 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 21, 2004 | Not classified | Z-0553-05 | Other | Pressure elbow may be partly occluded. |
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 · Cites it directly · ◆ in the 2016 descendants bar of FIG. 12 Class I recalls
- K131912Conchatherm Neptune Heated Humidifier, Comfort Flo Humidification System, Conchasmart ColumnTeleflex, Inc. · 2014 · 3 generations on · ◆ in the 2014 descendants bar of FIG. 12 Class I recalls
- K173280Neonatal ConchaSmart Breathing CircuitsTeleflexmedical, Inc. · 2018 · 3 generations on · ◆ in the 2018 descendants bar of FIG. 11 Class I recall
- K162242Comfort Flo Humidification SystemTeleflexmedical, Inc. · 2017 · 4 generations on · ◆ in the 2017 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 11 years and passes through 2 companies; a new generation was cleared every 4.2 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K033710 (Fisher & Paykel Healthcare, Ltd., 2004) has gone furthest, with 54 descendants of its own.
- 8 other devices also cite its predicate K983112.
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 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/K020332 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020332: Respiratory Humidifier, Model MR850.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020332
Report an extraction error
Are you the manufacturer?
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