510(k) · Cleared
ClearedOptiPAP Junior Flexi Tube US (OPTIPAPFUS); OptiPAP Junior Nasal Prongs XXS (OPTIPAPPXXS); OptiPAP Junior Nasal Prongs XS (OPTIPAPPXS); OptiPAP Junior Nasal Prongs S (OPTIPAPPS); OptiPAP Junior Nasal Prongs M (OPTIPAPPM); OptiPAP Junior Nasal Prongs L (OPTIPAPPL); OptiPAP Junior Nasal Prongs XL (OPTIPAPPXL); OptiPAP Junior Nasal Mask XXS (OPTIPAPMXXS); OptiPAP Junior Nasal Mask XS (OPTIPAPMXS); OptiPAP Junior Nasal Mask S (OPTIPAPMS); OptiPAP Junior Nasal Mask M (OPTIPAPMM); OptiPAP Jun
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fisher & Paykel Healthcare, Ltd. · SGR Noninvasive Positive Airway Pressure System, Facility Use
Cleared on Nov 19, 2025 as substantially equivalent to K032922 (Airways Ltd., Inc., 2004) and 1 other predicate after a 260-day review. Its family tree reaches back 2 generations to 1979.
- Decided
- Nov 19, 2025
- Review
- 260 days
- Class
- Class II
- Product code
- SGR
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K792018 (1979). 6 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K792018 | Silicone Rubber-BI Nasopharyngeal Air | Vesta, Inc. | 1979 | — |
| −1 | K032922 | Clarissa Infant Ncpap Cannula | Airways Ltd., Inc. | 2004 | — |
| 0 (this device) | K250651 | OptiPAP Junior Flexi Tube US (OPTIPAPFUS); OptiPAP Junior Nasal Prongs XXS… | Fisher & Paykel Healthcare, Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
| 1989 | 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 SGR? 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 SGR device
- #1 K251165 Saans (F4-01-00-000-000)score 11.5 · 4 generations · no Class I recall
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 |
|---|---|---|---|
| * | K032922 | Clarissa Infant Ncpap CannulaSummary page 5…ry Class II Product Code SGR III. PREDICATE DEVICES Primary Predicate Device: Clarissa Infant n-CPAP Cannula, K032922. Secondary Predicate Device: Hudson C.P.A.P Nasal Cannula, K871157. Reference Device: F&P FlexiTrunk Interf… | 2004 |
| * | K871157 | C.P.a.P. Nasal CannulaSummary page 5…. PREDICATE DEVICES Primary Predicate Device: Clarissa Infant n-CPAP Cannula, K032922. Secondary Predicate Device: Hudson C.P.A.P Nasal Cannula, K871157. Reference Device: F&P FlexiTrunk Interface, K100011. Reference Device: F&P Optiflow Junior 2, K222197. ==… | 1987 |
| † | K100011 | Fisher & Paykel Healthcare Bubble Cpap System | 2010 |
| † | K222197 | F&P Optiflow Junior 2/2+ Nasal Cannula Interface Range | 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 46 years and passes through 3 companies; a new generation was cleared every 24.9 years on median.
- 1 of the 6 ancestors has a recall of any class.
- 1 other device also cites its predicate K032922.
How does its category compare?
All SGR devicesSGR Noninvasive Positive Airway Pressure System, Facility Use: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · SGR
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · SGR
Too few SGR 510(k)s in any year since 2007 to give a median.
Recalls per year · SGR
No recall names SGR since 2007.
Adverse event reports per year · SGR
No MAUDE report names SGR since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
Fisher & Paykel Healthcare OptiPAP Junior is for single-patient use and is intended to deliver noninvasive positive airway pressure (PAP) therapy to spontaneously breathing patients who require respiratory support.
OptiPAP Junior is designed for use in hospital environments where the patient is continually monitored and must be prescribed by a physician. It is intended for use by trained medical professionals on a pediatric subpopulation that includes neonates and infants from birth up to two years of age.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250651 · printed Nov 4, 2026
Cite this page
510(k) Report. “K250651: OptiPAP Junior Flexi Tube US (OPTIPAPFUS); OptiPAP Junior Nasal Prongs XXS (OPTIPAPPXXS); OptiPAP Junior Nasal Prongs XS (OPTIPAPPXS); OptiPAP Junior Nasal Prongs S (OPTIPAPPS); OptiPAP Junior Nasal Prongs M (OPTIPAPPM); OptiPAP Junior Nasal Prongs L (OPTIPAPPL); OptiPAP Junior Nasal Prongs XL (OPTIPAPPXL); OptiPAP Junior Nasal Mask XXS (OPTIPAPMXXS); OptiPAP Junior Nasal Mask XS (OPTIPAPMXS); OptiPAP Junior Nasal Mask S (OPTIPAPMS); OptiPAP Junior Nasal Mask M (OPTIPAPMM); OptiPAP Jun.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K250651
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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