510(k) · Cleared
ClearedF&P Optiflow Oxygen Kit (AA451J)
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 Jun 13, 2024 as substantially equivalent to K211096 (Fisher & Paykel Healthcare, Ltd., 2022) and 1 other predicate after a 195-day review. Its family tree reaches back 12 generations to 1992.
- Decided
- Jun 13, 2024
- Review
- 195 days
- Class
- Class II
- Product code
- BTT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 12 generations to K913368 (1992). 37 ancestors in all, the oldest K811102 (1981). No later device cites it as a predicate yet.
- Root · 12 generations backK913368 Models MR700/MR720/MR730 Dual Servo Resp Humid AccFisher & Paykel Electronics, Ltd. · 1992
- 8 generations between
- 3 generations backK162553 AirSpiral Heated Breathing TubeFisher & Paykel Healthcare · 2018
- 2 generations backK212031 F&P 850 AirSpiral Adult NIV and NHF Circuit KitFisher & Paykel Healthcare, Ltd. · 2022
- 1 generation backK220703 F&P 950 Respiratory HumidifierFisher & Paykel Healthcare · 2023
- This deviceK233821 F&P Optiflow Oxygen Kit (AA451J)Fisher & Paykel Healthcare, Ltd. · 2024
Show all 12 generations
- Root · 12 generations backK913368 Models MR700/MR720/MR730 Dual Servo Resp Humid AccFisher & Paykel Electronics, Ltd. · 1992
- 11 generations backK953392 HC500 Servo-Controlled Heated Respiratory Humidifier (& Accessories)Fisher & Paykel Electronics, Ltd. · 1996
- 10 generations backK983112 Respiratory Humidifier, Model # MR850Fisher & Paykel Healthcare, Ltd. · 1998 · Recalled
- 9 generations backK020332 Respiratory Humidifier, Model MR850Fisher & Paykel Healthcare, Ltd. · 2003 · Recalled
- 8 generations backK033710 MR850 Respiratory Humidifier, Model MR850JHUFisher & Paykel Healthcare, Ltd. · 2004
- 7 generations backK073706 Respiratory Humidifier, Model MR850Fisher & Paykel Healthcare, Ltd. · 2008
- 6 generations backK092846 Airvo Series HumidifiersFisher & Paykel Healthcare, Ltd. · 2010
- 5 generations backK121975 Airvo Humidifier Myairo HumidifierFisher & Paykel Healthcare, Ltd. · 2013
- 4 generations backK131895 Airvo 2 Humidifier, Myairvo 2 HumidifierFisher & Paykel Healthcare, Ltd. · 2013 · Recalled
- 3 generations backK162553 AirSpiral Heated Breathing TubeFisher & Paykel Healthcare · 2018
- 2 generations backK212031 F&P 850 AirSpiral Adult NIV and NHF Circuit KitFisher & Paykel Healthcare, Ltd. · 2022
- 1 generation backK220703 F&P 950 Respiratory HumidifierFisher & Paykel Healthcare · 2023
- This deviceK233821 F&P Optiflow Oxygen Kit (AA451J)Fisher & Paykel Healthcare, Ltd. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K913368 | Models MR700/MR720/MR730 Dual Servo Resp Humid Acc | Fisher & Paykel Electronics, Ltd. | 1992 | — |
| −11 | K953392 | HC500 Servo-Controlled Heated Respiratory Humidifier (& Accessories) | Fisher & Paykel Electronics, Ltd. | 1996 | — |
| −10 | K983112 | Respiratory Humidifier, Model # MR850 | Fisher & Paykel Healthcare, Ltd. | 1998 | 5 |
| −9 | K020332 | Respiratory Humidifier, Model MR850 | Fisher & Paykel Healthcare, Ltd. | 2003 | 1 |
| −8 | K033710 | MR850 Respiratory Humidifier, Model MR850JHU | Fisher & Paykel Healthcare, Ltd. | 2004 | — |
| −7 | K073706 | Respiratory Humidifier, Model MR850 | Fisher & Paykel Healthcare, Ltd. | 2008 | — |
| −6 | K092846 | Airvo Series Humidifiers | Fisher & Paykel Healthcare, Ltd. | 2010 | — |
| −5 | K121975 | Airvo Humidifier Myairo Humidifier | Fisher & Paykel Healthcare, Ltd. | 2013 | — |
| −4 | K131895 | Airvo 2 Humidifier, Myairvo 2 Humidifier | Fisher & Paykel Healthcare, Ltd. | 2013 | 2 |
| −3 | K162553 | AirSpiral Heated Breathing Tube | Fisher & Paykel Healthcare | 2018 | — |
| −2 | K212031 | F&P 850 AirSpiral Adult NIV and NHF Circuit Kit | Fisher & Paykel Healthcare, Ltd. | 2022 | — |
| −1 | K220703 | F&P 950 Respiratory Humidifier | Fisher & Paykel Healthcare | 2023 | — |
| 0 (this device) | 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 |
| 2022 | 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? (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 |
|---|---|---|---|
| * | K211096 | Optiflow Oxygen KitSummary page 5…Class II (21 CFR §868.5450) Product Code BTT III. PREDICATE DEVICE • Primary Predicate Device: OptiflowTM Oxygen Kit, K211096 • Secondary Predicate: F&P 950 Respiratory Humidifier, K220703… | 2022 |
| * | K220703 | F&P 950 Respiratory HumidifierSummary page 5…BTT III. PREDICATE DEVICE • Primary Predicate Device: OptiflowTM Oxygen Kit, K211096 • Secondary Predicate: F&P 950 Respiratory Humidifier, K220703 1 F&P OptiflowTM Oxygen Kit (AA4… | 2023 |
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 32 years and passes through 3 companies; a new generation was cleared every 2.9 years on median.
- 4 of the 37 ancestors have a recall of any class.
- 1 other device also cites its predicate K211096.
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. 2024, 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?
This breathing set is an accessory to the F&P 950 Respiratory Humidifier to be used within the limits of its stated technical specifications.
It is intended for delivery of heated humidified high flow respiratory gases to adult patients in a hospital.
This product can be used on multiple patients when used with a hydrophobic filter between the product and the patient interface for a maximum of 24 hours after setup.
This product is for use by appropriately qualified healthcare professionals who perform anesthesia care and airway management.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233821 · printed Nov 6, 2026
Cite this page
510(k) Report. “K233821: F&P Optiflow Oxygen Kit (AA451J).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K233821
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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