510(k) · Cleared
ClearedSinexus Sinus Stent Gen 2, Model 1999-25
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sinexus, Inc. · LYA Splint, Intranasal Septal
Cleared on Nov 17, 2009 as substantially equivalent to K082276 (Synthemed, Inc., 2008) and 3 other predicates after a 103-day review. Its family tree reaches back 4 generations to 1997. 1 later device descends from it.
- Decided
- Nov 17, 2009
- Review
- 103 days
- Class
- Class I
- Product code
- LYA
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 4 generations to K972082 (1997). 9 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK972082 Custom Nasal SplintBoston Medical Products, Inc. · 1997
- 3 generations backK012532 Sepragel SinusGenzyme Corp. · 2001
- 2 generations backK063308 Advacoat Sinus Gel, Model 9100, Adva Sinus Stent, Model 9200Carbylan Biosurgery · 2006
- 1 generation backK070496 Advacoat Sinus Gel and StentCarbylan Biosurgery · 2007
- This deviceK092401 Sinexus Sinus Stent Gen 2, Model 1999-25Sinexus, Inc. · 2009
- Descendant · cites it directly · 0 of its ownK170913 Composite Removable Sinus Stent SystemSts Medical · 2017
Most influential descendants
Showing 1 of 1 · See all- K170913Composite Removable Sinus Stent SystemSts Medical · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K972082 | Custom Nasal Splint | Boston Medical Products, Inc. | 1997 | — |
| −3 | K012532 | Sepragel Sinus | Genzyme Corp. | 2001 | — |
| −2 | K063308 | Advacoat Sinus Gel, Model 9100, Adva Sinus Stent, Model 9200 | Carbylan Biosurgery | 2006 | — |
| −1 | K070496 | Advacoat Sinus Gel and Stent | Carbylan Biosurgery | 2007 | — |
| 0 (this device) | K092401 | Sinexus Sinus Stent Gen 2, Model 1999-25 | Sinexus, Inc. | 2009 | — |
| +1 | K170913 | Composite Removable Sinus Stent System | Sts Medical | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 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 LYA? 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 LYA device
- #1 K243655 TurbAlignscore 10.0 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K062628 | Sinexus Sinus Stent Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1…Sinus Stent Regulation: 21CFR 874.4780 Product Code: LYA Product Classification: Predicate Device: Sinexus Sinus Stent (K062628) and SyntheMed SinuShield (K082276) AdvaCoat Sinus Gel and Stent (K070496… | |
| * | K082276 | Synthemed DeviceSummary page 1…Product Code: LYA Product Classification: Predicate Device: Sinexus Sinus Stent (K062628) and SyntheMed SinuShield (K082276) AdvaCoat Sinus Gel and Stent (K070496) Nasopore Nasal Dressing (K052099)… | 2008 |
| * | K070496 | Advacoat Sinus Gel and StentSummary page 1…Device: Sinexus Sinus Stent (K062628) and SyntheMed SinuShield (K082276) AdvaCoat Sinus Gel and Stent (K070496) Nasopore Nasal Dressing (K052099) LactoSorb Ethmoid Stent (K002131) Devi… | 2007 |
| * | K052099 | Nasopore Nasal Dressing, Model Ndox-Yyy/ZZSummary page 1…SyntheMed SinuShield (K082276) AdvaCoat Sinus Gel and Stent (K070496) Nasopore Nasal Dressing (K052099) LactoSorb Ethmoid Stent (K002131) Device Description: The Gen 2 Sinexus Sinus Stent is a bio… | 2005 |
| * | K002131 | Lactosorb Ethmoid StentSummary page 1…AdvaCoat Sinus Gel and Stent (K070496) Nasopore Nasal Dressing (K052099) LactoSorb Ethmoid Stent (K002131) Device Description: The Gen 2 Sinexus Sinus Stent is a bioabsorbable stent designed to be pl… | 2001 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K170913 | Composite Removable Sinus Stent System | 2017 | 0 |
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 12 years and passes through 4 companies; a new generation was cleared every 4.3 years on median.
- None of the 9 ancestors has a recall.
- Of its descendants, K170913 (Sts Medical, 2017) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K082276.
How does its category compare?
All LYA devicesLYA Splint, Intranasal Septal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · LYA
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LYA
104in 2014
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LYA
No recall names LYA since 2007.
Adverse event reports per year · LYA
1in 2025
MAUDE reports naming product code LYA, 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 | 1 | — | 0 | 2 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 5 |
| 2010 | 0 | — | 0 | 2 |
| 2011 | 0 | — | 0 | 16 |
| 2012 | 1 | — | 0 | 16 |
| 2013 | 2 | — | 0 | 1 |
| 2014 | 5 | 104 | 0 | 4 |
| 2015 | 0 | — | 0 | 28 |
| 2016 | 1 | — | 0 | 28 |
| 2017 | 2 | — | 0 | 10 |
| 2018 | 2 | — | 0 | 19 |
| 2019 | 0 | — | 0 | 5 |
| 2020 | 1 | — | 0 | 6 |
| 2021 | 1 | — | 0 | 19 |
| 2022 | 0 | — | 0 | 8 |
| 2023 | 1 | — | 0 | 17 |
| 2024 | 0 | — | 0 | 7 |
| 2025 | 1 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Sinexus Sinus Stent Gen 2 is intended for use in adult patients following sinus surgery to maintain patency of the sinus by separating mucosal tissues, providing stabilization of the middle turbinate and preventing obstruction by adhesions between healing and/or inflamed mucosal surfaces.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092401 · printed Nov 4, 2026
Cite this page
510(k) Report. “K092401: Sinexus Sinus Stent Gen 2, Model 1999-25.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092401
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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