510(k) · Cleared
ClearedSilicone Rubber-BI Nasopharyngeal Air
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vesta, Inc. · BTQ Airway, Nasopharyngeal
Cleared on Nov 13, 1979 after a 35-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 8 later devices descend from it.
- Decided
- Nov 13, 1979
- Review
- 35 days
- Class
- Class I
- Product code
- BTQ
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 1 citing it directly.
- This deviceK792018 Silicone Rubber-BI Nasopharyngeal AirVesta, Inc. · 1979
- Descendant · cites it directly · 7 of its ownK032922 Clarissa Infant Ncpap CannulaAirways Ltd., Inc. · 2004
- Descendant · 2 generations on · 5 of its ownK090935 Minime Pediatric MaskSleepnet Corporation · 2009
- Descendant · 3 generations on · 3 of its ownK102224 Pixi Pediatric MaskResmed, Ltd. · 2010
- Descendant · 4 generations on · 1 of its ownK120920 Hsiner Cpap Silicone Nasal Mask Size XS/Petite Hsiner Nasal Pillow…Hsiner Company · 2012
- Descendant · 2 generations on · 0 of its ownK250651 OptiPAP Junior Flexi Tube US (OPTIPAPFUS); OptiPAP Junior Nasal…Fisher & Paykel Healthcare, Ltd. · 2025
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K032922Clarissa Infant Ncpap CannulaAirways Ltd., Inc. · 2004 · cites it directly7descendants
- K090935Minime Pediatric MaskSleepnet Corporation · 2009 · 2 generations on5descendants
- K102224Pixi Pediatric MaskResmed, Ltd. · 2010 · 3 generations on3descendants
- K120920Hsiner Cpap Silicone Nasal Mask Size XS/Petite Hsiner Nasal Pillow Mask Hsiner Infant…Hsiner Company · 2012 · 4 generations on1descendant
- K250651OptiPAP Junior Flexi Tube US (OPTIPAPFUS); OptiPAP Junior Nasal Prongs XXS…Fisher & Paykel Healthcare, Ltd. · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K792018 | Silicone Rubber-BI Nasopharyngeal Air | Vesta, Inc. | 1979 | — |
| +1 | K032922 | Clarissa Infant Ncpap Cannula | Airways Ltd., Inc. | 2004 | — |
| +2 | K090935 | Minime Pediatric Mask | Sleepnet Corporation | 2009 | — |
| +3 | K102224 | Pixi Pediatric Mask | Resmed, Ltd. | 2010 | — |
| +4 | K120920 | Hsiner Cpap Silicone Nasal Mask Size XS/Petite Hsiner Nasal Pillow Mask Hsiner… | Hsiner Company | 2012 | — |
| +2 | K250651 | OptiPAP Junior Flexi Tube US (OPTIPAPFUS); OptiPAP Junior Nasal Prongs XXS… | Fisher & Paykel Healthcare, Ltd. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 2 | 0 |
| 2016 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in BTQ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K032922 | Clarissa Infant Ncpap Cannula | 2004 | 7 |
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?
- Of its descendants, K032922 (Airways Ltd., Inc., 2004) has gone furthest, with 7 descendants of its own.
How does its category compare?
All BTQ devicesBTQ Airway, Nasopharyngeal: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · BTQ
FDA has decided no BTQ device since 2007.
Median 510(k) review, days · BTQ
Too few BTQ 510(k)s in any year since 2007 to give a median.
Recalls per year · BTQ
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · BTQ
59in 2025
MAUDE reports naming product code BTQ, 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 | 0 | — | 0 | 1 |
| 2008 | 0 | — | 0 | 14 |
| 2009 | 0 | — | 0 | 6 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 5 |
| 2012 | 0 | — | 0 | 4 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 3 |
| 2017 | 0 | — | 0 | 3 |
| 2018 | 0 | — | 0 | 3 |
| 2019 | 0 | — | 0 | 75 |
| 2020 | 0 | — | 0 | 13 |
| 2021 | 0 | — | 0 | 20 |
| 2022 | 0 | — | 0 | 20 |
| 2023 | 0 | — | 0 | 24 |
| 2024 | 0 | — | 1 | 22 |
| 2025 | 0 | — | 0 | 59 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K792018 · printed Nov 3, 2026
Cite this page
510(k) Report. “K792018: Silicone Rubber-BI Nasopharyngeal Air.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K792018
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026