510(k) · Cleared
ClearedArthrocare Nasastent CMC Nasal Dressing
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
ArthroCare Corporation · LYA Splint, Intranasal Septal
Cleared on Jun 16, 2014 as substantially equivalent to K113585 (Cogent Therapeutics, LLC, 2012) and 1 other predicate after a 60-day review. Its family tree reaches back 5 generations to 1982.
- Decided
- Jun 16, 2014
- Review
- 60 days
- Class
- Class I
- Product code
- LYA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K821150 (1982). 18 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK821150 NU-Gauze SpongeJohnson & Johnson Professionals, Inc. · 1982
- 4 generations backK984069 Entaxis Nasal PackingLes Laboratorires Brothier, S.A. · 1999
- 3 generations backK993362 HylasineBiomatrix, Inc. · 2000
- 2 generations backK043035 Sepragel Ent Bioresorbable Packing/StentGenzyme Corporation · 2005
- 1 generation backK113585 Nasal/Epistaxis PackCogent Therapeutics, LLC · 2012
- This deviceK140992 Arthrocare Nasastent CMC Nasal DressingArthroCare Corporation · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K821150 | NU-Gauze Sponge | Johnson & Johnson Professionals, Inc. | 1982 | — |
| −4 | K984069 | Entaxis Nasal Packing | Les Laboratorires Brothier, S.A. | 1999 | — |
| −3 | K993362 | Hylasine | Biomatrix, Inc. | 2000 | — |
| −2 | K043035 | Sepragel Ent Bioresorbable Packing/Stent | Genzyme Corporation | 2005 | — |
| −1 | K113585 | Nasal/Epistaxis Pack | Cogent Therapeutics, LLC | 2012 | — |
| 0 (this device) | K140992 | Arthrocare Nasastent CMC Nasal Dressing | ArthroCare Corporation | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1997 | 3 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 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? (3)
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 |
|---|---|---|---|
| * | K113585 | Nasal/Epistaxis Pack | 2012 |
| * | K052099 | Nasopore Nasal Dressing, Model Ndox-Yyy/ZZSummary page 1…asal/Epistaxis Pack KI 13585 (April 25, 2012) Polyganics NasoPore® Nasal Dressing, Model NDOX-YYY/ZZ K052099 (November 21, 2005) Hemostasis NexPak Intranasal Splint Class 1,Exempt Description Nasa… | 2005 |
| * | — | Hemostasis NexPak Intranasal Splint Named without a submission number |
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 32 years and passes through 6 companies; a new generation was cleared every 5.3 years on median.
- None of the 18 ancestors has a recall.
- 2 other devices also cite its predicate K113585.
How does its category compare?
All LYA devicesLYA Splint, Intranasal Septal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 ArthroCare NasaStent is intended to minimize bleeding and edema and to prevent adhesions between the septum and the nasal cavity. It is placed in the nasal cavity after surgery or trauma. NasaStern is constructed from absorbent CarboxyMethyl Cellulose (CMC) material.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140992 · printed Nov 3, 2026
Cite this page
510(k) Report. “K140992: Arthrocare Nasastent CMC Nasal Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K140992
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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