510(k) · Cleared
ClearedF&P Optiflow Junior 2/2+ Nasal Cannula Interface Range
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 Apr 6, 2023 as substantially equivalent to K162553 (Fisher & Paykel Healthcare, 2018) after a 258-day review. Its family tree reaches back 10 generations to 1992. 3 later devices descend from it.
- Decided
- Apr 6, 2023
- Review
- 258 days
- Class
- Class II
- Product code
- BTT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K913368 (1992). 22 ancestors in all, the oldest K902506 (1991). 3 later devices descend from it, 3 citing it directly.
- Root · 10 generations backK913368 Models MR700/MR720/MR730 Dual Servo Resp Humid AccFisher & Paykel Electronics, Ltd. · 1992
- 6 generations between
- 3 generations backK121975 Airvo Humidifier Myairo HumidifierFisher & Paykel Healthcare, Ltd. · 2013
- 2 generations backK131895 Airvo 2 Humidifier, Myairvo 2 HumidifierFisher & Paykel Healthcare, Ltd. · 2013 · Recalled
- 1 generation backK162553 AirSpiral Heated Breathing TubeFisher & Paykel Healthcare · 2018
- This deviceK222197 F&P Optiflow Junior 2/2+ Nasal Cannula Interface RangeFisher & Paykel Healthcare, Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK250312 Hudson RCI® Comfort Flo Nasal Cannula Premature, Infant; Hudson RCI®…Medline Industries, LP · 2025
- Descendant · cites it directly · 0 of its ownK241778 Hudson RCI Comfort Flo® CubCannula™Medline Industries, LP · 2024
- Descendant · cites it directly · 0 of its ownK240163 Hudson RCI® Comfort Flo Nasal Cannula; Hudson RCI® Comfort Flo Plus…Medline Industries, LP · 2024
Show all 10 generations
- Root · 10 generations backK913368 Models MR700/MR720/MR730 Dual Servo Resp Humid AccFisher & Paykel Electronics, Ltd. · 1992
- 9 generations backK953392 HC500 Servo-Controlled Heated Respiratory Humidifier (& Accessories)Fisher & Paykel Electronics, Ltd. · 1996
- 8 generations backK983112 Respiratory Humidifier, Model # MR850Fisher & Paykel Healthcare, Ltd. · 1998 · Recalled
- 7 generations backK020332 Respiratory Humidifier, Model MR850Fisher & Paykel Healthcare, Ltd. · 2003 · Recalled
- 6 generations backK033710 MR850 Respiratory Humidifier, Model MR850JHUFisher & Paykel Healthcare, Ltd. · 2004
- 5 generations backK073706 Respiratory Humidifier, Model MR850Fisher & Paykel Healthcare, Ltd. · 2008
- 4 generations backK092846 Airvo Series HumidifiersFisher & Paykel Healthcare, Ltd. · 2010
- 3 generations backK121975 Airvo Humidifier Myairo HumidifierFisher & Paykel Healthcare, Ltd. · 2013
- 2 generations backK131895 Airvo 2 Humidifier, Myairvo 2 HumidifierFisher & Paykel Healthcare, Ltd. · 2013 · Recalled
- 1 generation backK162553 AirSpiral Heated Breathing TubeFisher & Paykel Healthcare · 2018
- This deviceK222197 F&P Optiflow Junior 2/2+ Nasal Cannula Interface RangeFisher & Paykel Healthcare, Ltd. · 2023
Most influential descendants
Showing 3 of 3 · See all- K250312Hudson RCI® Comfort Flo Nasal Cannula Premature, Infant; Hudson RCI® Comfort Flo Plus…Medline Industries, LP · 2025 · cites it directly0descendants
- K241778Hudson RCI Comfort Flo® CubCannula™Medline Industries, LP · 2024 · cites it directly0descendants
- K240163Hudson RCI® Comfort Flo Nasal Cannula; Hudson RCI® Comfort Flo Plus CannulaMedline Industries, LP · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K913368 | Models MR700/MR720/MR730 Dual Servo Resp Humid Acc | Fisher & Paykel Electronics, Ltd. | 1992 | — |
| −9 | K953392 | HC500 Servo-Controlled Heated Respiratory Humidifier (& Accessories) | Fisher & Paykel Electronics, Ltd. | 1996 | — |
| −8 | K983112 | Respiratory Humidifier, Model # MR850 | Fisher & Paykel Healthcare, Ltd. | 1998 | 5 |
| −7 | K020332 | Respiratory Humidifier, Model MR850 | Fisher & Paykel Healthcare, Ltd. | 2003 | 1 |
| −6 | K033710 | MR850 Respiratory Humidifier, Model MR850JHU | Fisher & Paykel Healthcare, Ltd. | 2004 | — |
| −5 | K073706 | Respiratory Humidifier, Model MR850 | Fisher & Paykel Healthcare, Ltd. | 2008 | — |
| −4 | K092846 | Airvo Series Humidifiers | Fisher & Paykel Healthcare, Ltd. | 2010 | — |
| −3 | K121975 | Airvo Humidifier Myairo Humidifier | Fisher & Paykel Healthcare, Ltd. | 2013 | — |
| −2 | K131895 | Airvo 2 Humidifier, Myairvo 2 Humidifier | Fisher & Paykel Healthcare, Ltd. | 2013 | 2 |
| −1 | K162553 | AirSpiral Heated Breathing Tube | Fisher & Paykel Healthcare | 2018 | — |
| 0 (this device) | K222197 | F&P Optiflow Junior 2/2+ Nasal Cannula Interface Range | Fisher & Paykel Healthcare, Ltd. | 2023 | — |
| +1 | K250312 | Hudson RCI® Comfort Flo Nasal Cannula Premature, Infant; Hudson RCI® Comfort… | Medline Industries, LP | 2025 | — |
| +1 | K241778 | Hudson RCI Comfort Flo® CubCannula™ | Medline Industries, LP | 2024 | — |
| +1 | K240163 | Hudson RCI® Comfort Flo Nasal Cannula; Hudson RCI® Comfort Flo Plus Cannula | Medline Industries, LP | 2024 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 2 | 0 |
| 2025 | 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 K262268 Optiflow Oxygen Kit (AA484J)score 14.9 · 11 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 |
|---|---|---|---|
| * | K162553 | AirSpiral Heated Breathing TubeSummary page 5…ory Class II Product Code BTT III. PREDICATE DEVICE Predicate Device F&P Optiflow Junior Nasal Cannula K162553 Page 1 of 9 IV.… | 2018 |
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 4.0 years on median.
- 3 of the 22 ancestors have a recall of any class.
- Of its descendants, K250312 (Medline Industries, LP, 2025) has gone furthest, with 0 descendants of its own.
- 7 other devices also cite its predicate K162553.
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 Optiflow Junior 2: The Fisher & Paykel Healthcare Optiflow Junior 2 nasal cannula is a single use nasal cannula intended for use with a nasal high flow therapy (NHF) system to deliver heated and humidified nasal high flow therapy to spontaneously breathing patients. This product is designed for use in hospital environments and must be prescribed by a physician. The intended pediatric subpopulations targeted for use of the F&P Optiflow Junior 2 Nasal…
Read the full statement (402 words)
F&P Optiflow Junior 2:
The Fisher & Paykel Healthcare Optiflow Junior 2 nasal cannula is a single use nasal cannula intended for use with a nasal high flow therapy (NHF) system to deliver heated and humidified nasal high flow therapy to spontaneously breathing patients.
This product is designed for use in hospital environments and must be prescribed by a physician.
The intended pediatric subpopulations targeted for use of the F&P Optiflow Junior 2 Nasal Cannula range includes:
*Neonates, birth up to 1 month of age
* Infants, 1 month up to 2 years of age
* Children, 2 years up to 12 years of age
F&P Optiflow Junior 2+
The Fisher & Paykel Healthcare Optiflow Junior 2+ nasal cannula is a single use nasal cannula intended for use with a nasal high flow therapy (NHF) system to deliver heated and humidified nasal high flow therapy to spontaneously breathing patients.
This product is designed for use in hospital environments and must be prescribed by a physician.
The intended pediatric subpopulation targeted for use on the F&P Optiflow Junior 2+ Nasal Cannula includes:
* Infants, 1 month up to 2 years of age
* Children, 2 years up to 12 years of age
F&P Optiflow Junior 2 HM Cannula
The Fisher & Paykel Healthcare Optiflow Junior 2 nasal cannula is a single use nasal cannula intended for use with a nasal high flow therapy (NIIF) system to deliver heated and humidified nasal high flow therapy to spontaneously breathing patients.
This product is designed for use in long term care environments and must be prescribed by a physician.
The intended pediatric subpopulations targeted for use of the F&P Optiflow Junior 2 Nasal Cannula range includes:
* Infants, 1 month up to 2 years of age
* Children, 2 years up to 12 years of age
F&P Optiflow Junior 2+ HM Cannula
The Fisher & Paykel Healthcare Optiflownm Junior 2+ nasal cannula is a single use nasal cannula intended for use with a nasal high flow (NHF) therapy system to deliver heated and humidified nasal high flow therapy to spontaneously breathing patients.
This product is designed for use in long term care environments and must be prescribed by a physician.
The intended pediatric subpopulation targeted for use on the F&P Optiflow Junior 2+ Nasal Cannula includes:
* Infants, 1 month up to 2 years of age
* Children, 2 years up to 12 years of age
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222197 · printed Nov 6, 2026
Cite this page
510(k) Report. “K222197: F&P Optiflow Junior 2/2+ Nasal Cannula Interface Range.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K222197
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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