510(k) · Cleared
ClearedF&P 820 Humidification System
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 Sep 5, 2023 as substantially equivalent to K143646 (Fisher & Paykel Healthcare, Ltd., 2015) and 2 other predicates after a 271-day review. Its family tree reaches back 9 generations to 1992.
- Decided
- Sep 5, 2023
- Review
- 271 days
- Class
- Class II
- Product code
- BTT
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 9 generations to K913368 (1992). 14 ancestors in all, the oldest K902506 (1991). No later device cites it as a predicate yet.
- Root · 9 generations backK913368 Models MR700/MR720/MR730 Dual Servo Resp Humid AccFisher & Paykel Electronics, Ltd. · 1992
- 5 generations between
- 3 generations backK100554 Respiratory Humidifier , Heated Delivery System, Adaptor, Models…Fisher & Paykel Healthcare, Ltd. · 2010
- 2 generations backK131957 MR810RESPIRATORY Humidifier, 900MR810 Adult Single Limb Circuit…Fisher & Paykel Healthcare, Ltd. · 2013
- 1 generation backK143646 MR810 System, 900MR810 Adult Single Limb Circuit, 900MR810E Adult…Fisher & Paykel Healthcare, Ltd. · 2015
- This deviceK223684 F&P 820 Humidification SystemFisher & Paykel Healthcare, Ltd. · 2023
Show all 9 generations
- Root · 9 generations backK913368 Models MR700/MR720/MR730 Dual Servo Resp Humid AccFisher & Paykel Electronics, Ltd. · 1992
- 8 generations backK953392 HC500 Servo-Controlled Heated Respiratory Humidifier (& Accessories)Fisher & Paykel Electronics, Ltd. · 1996
- 7 generations backK983112 Respiratory Humidifier, Model # MR850Fisher & Paykel Healthcare, Ltd. · 1998 · Recalled
- 6 generations backK020332 Respiratory Humidifier, Model MR850Fisher & Paykel Healthcare, Ltd. · 2003 · Recalled
- 5 generations backK033710 MR850 Respiratory Humidifier, Model MR850JHUFisher & Paykel Healthcare, Ltd. · 2004
- 4 generations backK073706 Respiratory Humidifier, Model MR850Fisher & Paykel Healthcare, Ltd. · 2008
- 3 generations backK100554 Respiratory Humidifier , Heated Delivery System, Adaptor, Models…Fisher & Paykel Healthcare, Ltd. · 2010
- 2 generations backK131957 MR810RESPIRATORY Humidifier, 900MR810 Adult Single Limb Circuit…Fisher & Paykel Healthcare, Ltd. · 2013
- 1 generation backK143646 MR810 System, 900MR810 Adult Single Limb Circuit, 900MR810E Adult…Fisher & Paykel Healthcare, Ltd. · 2015
- This deviceK223684 F&P 820 Humidification SystemFisher & Paykel Healthcare, Ltd. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K913368 | Models MR700/MR720/MR730 Dual Servo Resp Humid Acc | Fisher & Paykel Electronics, Ltd. | 1992 | — |
| −8 | K953392 | HC500 Servo-Controlled Heated Respiratory Humidifier (& Accessories) | Fisher & Paykel Electronics, Ltd. | 1996 | — |
| −7 | K983112 | Respiratory Humidifier, Model # MR850 | Fisher & Paykel Healthcare, Ltd. | 1998 | 5 |
| −6 | K020332 | Respiratory Humidifier, Model MR850 | Fisher & Paykel Healthcare, Ltd. | 2003 | 1 |
| −5 | K033710 | MR850 Respiratory Humidifier, Model MR850JHU | Fisher & Paykel Healthcare, Ltd. | 2004 | — |
| −4 | K073706 | Respiratory Humidifier, Model MR850 | Fisher & Paykel Healthcare, Ltd. | 2008 | — |
| −3 | K100554 | Respiratory Humidifier , Heated Delivery System, Adaptor, Models MR880, RT241… | Fisher & Paykel Healthcare, Ltd. | 2010 | — |
| −2 | K131957 | MR810RESPIRATORY Humidifier, 900MR810 Adult Single Limb Circuit, 900MR810E… | Fisher & Paykel Healthcare, Ltd. | 2013 | — |
| −1 | K143646 | MR810 System, 900MR810 Adult Single Limb Circuit, 900MR810E Adult Dual Limb… | Fisher & Paykel Healthcare, Ltd. | 2015 | — |
| 0 (this device) | 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 |
| 2001 | 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? (3)
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 |
|---|---|---|---|
| * | K143646 | MR810 System, 900MR810 Adult Single Limb Circuit, 900MR810E Adult Dual Limb CircuitSummary page 6…Page 1 of 9 III. PREDICATE DEVICE • Primary Predicate device: 510(k) Number Device Name K143646 F&P MR810 Respiratory Humidifier • Secondary Predicate devices: 510(k)… | 2015 |
| * | K983112 | Respiratory Humidifier, Model # MR850Summary page 6…er • Secondary Predicate devices: 510(k) Reason for secondary predicate Device Name Number K983112 Adult breathing circuit (RT102) Used as a predicate for the F&P 820A10J… | 1998 |
| * | K003973 | Respiratory Humidifier, Model HC150Summary page 6…Adult breathing circuit (RT102) Used as a predicate for the F&P 820A10J accessory breathing circuit kits. K003973 F&P humidification chamber Used as a predicate for the F&P MR325 (HC325)… | 2001 |
| † | K152029 | Hamilton-H900, Hamilton-BC8022, Hamilton-BC4022, Hamilton-BC8010, Hamilton-BC4010 | 2016 |
What descends from it?
No later submission names this one as a predicate yet.
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 2 companies; a new generation was cleared every 3.5 years on median.
- 2 of the 14 ancestors have a recall of any class.
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 820 System Humidifier Base: The F&P 820 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. This system is intended for both noninvasive and invasive therapies. The addition of heat and humidity to the supply of cold and dry respiratory gases provided through noninvasive or invasive ventilation is beneficial…
Read the full statement (366 words)
F&P 820 System Humidifier Base:
The F&P 820 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.
This system is intended for both noninvasive and invasive therapies. The addition of heat and humidity to the supply of cold and dry respiratory gases provided through noninvasive or invasive ventilation is beneficial to prevent drying of the patient’s airways.
The F&P 820 System is designed for adult and pediatric patients (excluding neonate), requiring a flow range ≥ 5 L/min. It is designed for use in hospitals, long term care facilities and homes, under the prescription of qualified medical professionals.
F&P 820A10 Breathing Tubes:
The F&P 820 series breathing tubes are an accessory to the F&P 820 System and are compatible with F&P 820 series humidifiers.
The F&P 820 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.
This system is intended for both noninvasive and invasive therapies. The addition of heat and humidity to the supply of cold and dry respiratory gases provided through noninvasive or invasive ventilation is beneficial to prevent drying of the patient’s airways.
This system is designed for adult and pediatric (excluding neonate) use in hospitals, long term care facilities and homes, under the prescription of qualified medical professionals.
F&P MR325 Humidification Chamber:
The MR325 humidification chamber is an accessory to the F&P 820 System and is compatible with F&P 820 series humidifiers.
The F&P 820 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.
This system is intended for both noninvasive and invasive therapies. The addition of heat and humidity to the supply of cold and dry respiratory gases provided through noninvasive or invasive ventilation is beneficial to prevent drying of the patient’s airways.
This system is designed for adult and pediatric (excluding neonate) use in hospitals, long term care facilities and homes, under the prescription of qualified medical professionals.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223684 · printed Nov 5, 2026
Cite this page
510(k) Report. “K223684: F&P 820 Humidification System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K223684
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