510(k) · Cleared
ClearedF&P 950 Respiratory Humidifier
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fisher & Paykel Healthcare · BTT Humidifier, Respiratory Gas, (Direct Patient Interface)
Cleared on Jun 16, 2023 as substantially equivalent to K110019 (Fisher & Paykel Healthcare, Ltd., 2012) and 5 other predicates after a 463-day review. Its family tree reaches back 11 generations to 1992. 1 later device descends from it.
- Decided
- Jun 16, 2023
- Review
- 463 days
- Class
- Class II
- Product code
- BTT
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 11 generations to K913368 (1992). 35 ancestors in all, the oldest K811102 (1981). 1 later device descends from it, 1 citing it directly.
- Root · 11 generations backK913368 Models MR700/MR720/MR730 Dual Servo Resp Humid AccFisher & Paykel Electronics, Ltd. · 1992
- 7 generations between
- 3 generations backK131895 Airvo 2 Humidifier, Myairvo 2 HumidifierFisher & Paykel Healthcare, Ltd. · 2013 · Recalled
- 2 generations backK162553 AirSpiral Heated Breathing TubeFisher & Paykel Healthcare · 2018
- 1 generation backK212031 F&P 850 AirSpiral Adult NIV and NHF Circuit KitFisher & Paykel Healthcare, Ltd. · 2022
- This deviceK220703 F&P 950 Respiratory HumidifierFisher & Paykel Healthcare · 2023
- Descendant · cites it directly · 0 of its ownK233821 F&P Optiflow Oxygen Kit (AA451J)Fisher & Paykel Healthcare, Ltd. · 2024
Show all 11 generations
- Root · 11 generations backK913368 Models MR700/MR720/MR730 Dual Servo Resp Humid AccFisher & Paykel Electronics, Ltd. · 1992
- 10 generations backK953392 HC500 Servo-Controlled Heated Respiratory Humidifier (& Accessories)Fisher & Paykel Electronics, Ltd. · 1996
- 9 generations backK983112 Respiratory Humidifier, Model # MR850Fisher & Paykel Healthcare, Ltd. · 1998 · Recalled
- 8 generations backK020332 Respiratory Humidifier, Model MR850Fisher & Paykel Healthcare, Ltd. · 2003 · Recalled
- 7 generations backK033710 MR850 Respiratory Humidifier, Model MR850JHUFisher & Paykel Healthcare, Ltd. · 2004
- 6 generations backK073706 Respiratory Humidifier, Model MR850Fisher & Paykel Healthcare, Ltd. · 2008
- 5 generations backK092846 Airvo Series HumidifiersFisher & Paykel Healthcare, Ltd. · 2010
- 4 generations backK121975 Airvo Humidifier Myairo HumidifierFisher & Paykel Healthcare, Ltd. · 2013
- 3 generations backK131895 Airvo 2 Humidifier, Myairvo 2 HumidifierFisher & Paykel Healthcare, Ltd. · 2013 · Recalled
- 2 generations backK162553 AirSpiral Heated Breathing TubeFisher & Paykel Healthcare · 2018
- 1 generation backK212031 F&P 850 AirSpiral Adult NIV and NHF Circuit KitFisher & Paykel Healthcare, Ltd. · 2022
- This deviceK220703 F&P 950 Respiratory HumidifierFisher & Paykel Healthcare · 2023
Most influential descendants
Showing 1 of 1 · See all- K233821F&P Optiflow Oxygen Kit (AA451J)Fisher & Paykel Healthcare, Ltd. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K913368 | Models MR700/MR720/MR730 Dual Servo Resp Humid Acc | Fisher & Paykel Electronics, Ltd. | 1992 | — |
| −10 | K953392 | HC500 Servo-Controlled Heated Respiratory Humidifier (& Accessories) | Fisher & Paykel Electronics, Ltd. | 1996 | — |
| −9 | K983112 | Respiratory Humidifier, Model # MR850 | Fisher & Paykel Healthcare, Ltd. | 1998 | 5 |
| −8 | K020332 | Respiratory Humidifier, Model MR850 | Fisher & Paykel Healthcare, Ltd. | 2003 | 1 |
| −7 | K033710 | MR850 Respiratory Humidifier, Model MR850JHU | Fisher & Paykel Healthcare, Ltd. | 2004 | — |
| −6 | K073706 | Respiratory Humidifier, Model MR850 | Fisher & Paykel Healthcare, Ltd. | 2008 | — |
| −5 | K092846 | Airvo Series Humidifiers | Fisher & Paykel Healthcare, Ltd. | 2010 | — |
| −4 | K121975 | Airvo Humidifier Myairo Humidifier | Fisher & Paykel Healthcare, Ltd. | 2013 | — |
| −3 | K131895 | Airvo 2 Humidifier, Myairvo 2 Humidifier | Fisher & Paykel Healthcare, Ltd. | 2013 | 2 |
| −2 | K162553 | AirSpiral Heated Breathing Tube | Fisher & Paykel Healthcare | 2018 | — |
| −1 | K212031 | F&P 850 AirSpiral Adult NIV and NHF Circuit Kit | Fisher & Paykel Healthcare, Ltd. | 2022 | — |
| 0 (this device) | K220703 | F&P 950 Respiratory Humidifier | Fisher & Paykel Healthcare | 2023 | — |
| +1 | 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 |
|---|---|---|
| 1981 | 1 | 0 |
| 1983 | 1 | 0 |
| 1988 | 1 | 0 |
| 1991 | 2 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 4 | 0 |
| 1998 | 2 | 0 |
| 2000 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2012 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (6)
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 |
|---|---|---|---|
| * | K110019 | Respiratory HumidiferSummary page 5…Page 1 of 23 III. PREDICATE DEVICE • Primary Predicate device: 510(k) Number Device Name K110019 F&P MR850 Respiratory Humidifier • Secondary Predicate devices: 510(k)… | 2012 |
| * | K122432 | Adult Evaqua 2' Dual Heated Breathing CircuitsSummary page 5…midifier • Secondary Predicate devices: 510(k) Reason for secondary predicate Device Name Number K122432 Adult Evaqua 2 (RT380/RT385) Used as a predicate for the 950A80J, 950A81J,… | 2012 |
| * | K162553 | AirSpiral Heated Breathing TubeSummary page 5…ua 2 (RT380/RT385) Used as a predicate for the 950A80J, 950A81J, and 950A82J accessory breathing circuit kits. K162553 F&P AirSpiral Heated Breathing Used as a predicate for the 950A40J, 950N40J, Tube… | 2018 |
| * | K103767 | Dual Heated Infant Vreathing CirouitsSummary page 5…950N40J, Tube 950P40J, and AA451SU accessory breathing circuit kits. K103767 F&P Infant Evaqua 2 (RT265/266) Used as a predicate for the 950N80J, 950N81J,… | 2012 |
| * | K212031 | F&P 850 AirSpiral Adult NIV and NHF Circuit Kit Cleared while this submission was under review Summary page 5…and 950P81J accessory breathing circuit kits. F&P 850 AirSpiral Adult NIV And Used as a predicate for the 950A60J, and K212031 NHF Circuit Kit (850A61) 950A61J accessory breathing circuit kits. Neonatal Breathi… | 2022 |
| * | K020332 | Respiratory Humidifier, Model MR850Summary page 5…rcuit Kit (850A61) 950A61J accessory breathing circuit kits. Neonatal Breathing Circuits Used as a predicate for the 950N61J accessory K020332 (RT130/RT131) breathing circuit kit. • Reference device(s): 510(k) Devi… | 2003 |
| † | K050927 | RT019 Inspiratory/Expiratory Filter | 2005 |
| † | K173770 | OJR215 Pressure Relief Manifold | 2019 |
| † | K131895 | Airvo 2 Humidifier, Myairvo 2 Humidifier | 2013 |
| † | K211096 | Optiflow Oxygen Kit | 2022 |
| † | K982454 | Bipap Vision Ventilatory Support | 1998 |
| † | K031745 | Infant Flow Plus Infant Cpap System with Sipap Function | 2004 |
| † | K091111 | RTC Metered Dose Inhaler Adapters-Single Patient Use, Model RTC 24-V, RTC Mdi Adapter… | 2009 |
| † | K133666 | RT016 Inspiratory Filter | 2014 |
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 |
|---|---|---|---|
| K233821 | F&P Optiflow Oxygen Kit (AA451J) | 2024 | 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 31 years and passes through 3 companies; a new generation was cleared every 2.9 years on median.
- 4 of the 35 ancestors have a recall of any class.
- Of its descendants, K233821 (Fisher & Paykel Healthcare, Ltd., 2024) has gone furthest, with 0 descendants of its own.
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. 2023, 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?
F&P 950 Respiratory Humidifier The F&P 950 Respiratory Humidifier is intended to provide heat and humidity to respiratory gases delivered to patients. It is for use in a hospital or long-term care facility by a health professional. F&P 950 Breathing Circuit Kits: 950A80J, 950A81J, 950A82J, 950A60J, 950A61J, 950A40J, AA451SU The breathing set is an accessory to the F&P 950 Respiratory Humidifier. It is intended for delivery of heated humidified…
Read the full statement (174 words)
F&P 950 Respiratory Humidifier
The F&P 950 Respiratory Humidifier is intended to provide heat and humidity to respiratory gases delivered to patients. It is for use in a hospital or long-term care facility by a health professional.
F&P 950 Breathing Circuit Kits: 950A80J, 950A81J, 950A82J, 950A60J, 950A61J, 950A40J, AA451SU
The breathing set is an accessory to the F&P 950 Respiratory Humidifier. It is intended for delivery of heated humidified respiratory gases to adult, adolescent and child patients, within the limits of its stated technical specifications.
F&P 950 Breathing Circuit Kits: 950P81J, 950P40J
The breathing set is an accessory to the F&P 950 Respiratory Humidifier. It is intended for delivery of heated humidified respiratory gases to neonatal, infant, child and adolescent patients, within the limits of its stated technical specifications.
F&P 950 Breathing Circuit Kits: 950N80J, 950N81J, 950N61J, 950N40J
The breathing set is an accessory to the F&P 950 Respiratory Humidifier. It is intended for delivery of heated humidified respiratory gases to neonatal, infant and child patients, within the limits of its stated technical specifications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K220703 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220703: F&P 950 Respiratory Humidifier.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220703
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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