510(k) · Cleared
ClearedOptiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J)
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 Dec 19, 2025 as substantially equivalent to K234058 (Fisher & Paykel Healthcare, Ltd., 2024) after a 66-day review. Its family tree reaches back 12 generations to 1992.
- Decided
- Dec 19, 2025
- Review
- 66 days
- Class
- Class II
- Product code
- BTT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K913368 (1992). 24 ancestors in all, the oldest K902506 (1991). 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 backK201723 F&P Optiflow Nasal Oxygen Cannula with CO2 SamplingFisher & Paykel Healthcare, Ltd. · 2021
- 1 generation backK234058 F&P Optiflow Filtered Nasal Interface with Anesthesia Mask…Fisher & Paykel Healthcare, Ltd. · 2024
- This deviceK253479 Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J)Fisher & Paykel Healthcare, Ltd. · 2025
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 backK201723 F&P Optiflow Nasal Oxygen Cannula with CO2 SamplingFisher & Paykel Healthcare, Ltd. · 2021
- 1 generation backK234058 F&P Optiflow Filtered Nasal Interface with Anesthesia Mask…Fisher & Paykel Healthcare, Ltd. · 2024
- This deviceK253479 Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J)Fisher & Paykel Healthcare, Ltd. · 2025
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 | K201723 | F&P Optiflow Nasal Oxygen Cannula with CO2 Sampling | Fisher & Paykel Healthcare, Ltd. | 2021 | — |
| −1 | K234058 | F&P Optiflow Filtered Nasal Interface with Anesthesia Mask Compatibility… | Fisher & Paykel Healthcare, Ltd. | 2024 | — |
| 0 (this device) | K253479 | Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J) | Fisher & Paykel Healthcare, Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2004 | 2 | 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? (1)
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 |
|---|---|---|---|
| * | K234058 | F&P Optiflow Filtered Nasal Interface with Anesthesia Mask Compatibility (AA041J)Summary page 5…868.5450) Product Code BTT III. PREDICATE DEVICE Predicate Device: F&P Optiflow Filtered Nasal Interface with Anesthesia Mask Compatibility, K234058. Reference Device: F&P Optiflow Nasal Oxygen Cannula with CO2 sampling, K201723.… | 2024 |
| † | K201723 | F&P Optiflow Nasal Oxygen Cannula with CO2 Sampling | 2021 |
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 33 years and passes through 3 companies; a new generation was cleared every 2.9 years on median.
- 3 of the 24 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. 2025, 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 product is intended for delivery of respiratory gases to adult patients in hospitals. This product is indicated for the delivery of nasal high flow (NHF) and low-flow oxygen by appropriately qualified healthcare professionals. Qualitative carbon dioxide (CO2) sampling can be used at nasal cannula flow rates from 5 to 50 L/min in operating and procedure rooms. This product can be used for pre-oxygenation, short-term supplemental oxygenation (up to 10…
Read the full statement (115 words)
This product is intended for delivery of respiratory gases to adult patients in hospitals.
This product is indicated for the delivery of nasal high flow (NHF) and low-flow oxygen by appropriately qualified healthcare professionals.
Qualitative carbon dioxide (CO2) sampling can be used at nasal cannula flow rates from 5 to 50 L/min in operating and procedure rooms.
This product can be used for pre-oxygenation, short-term supplemental oxygenation (up to 10 minutes) during intubation, and allows an anesthesia mask to be placed over the nasal interface to perform mask ventilation, by individuals who perform anesthesia care or airway management.
This product is not intended for apneic ventilation.
This product is not indicated for use during CPR.
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/K253479 · printed Nov 4, 2026
Cite this page
510(k) Report. “K253479: Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K253479
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