510(k) · Cleared
ClearedNasal/Epistaxis Pack
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cogent Therapeutics, LLC · LYA Splint, Intranasal Septal
Cleared on Apr 25, 2012 as substantially equivalent to K052099 (Polyganics B.V.,, 2005) and 4 other predicates after a 142-day review. Its family tree reaches back 4 generations to 1982. 7 later devices descend from it.
- Decided
- Apr 25, 2012
- Review
- 142 days
- Class
- Class I
- Product code
- LYA
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 4 generations to K821150 (1982). 17 ancestors in all. 7 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK821150 NU-Gauze SpongeJohnson & Johnson Professionals, Inc. · 1982
- 3 generations backK984069 Entaxis Nasal PackingLes Laboratorires Brothier, S.A. · 1999
- 2 generations backK993362 HylasineBiomatrix, Inc. · 2000
- 1 generation backK043035 Sepragel Ent Bioresorbable Packing/StentGenzyme Corporation · 2005
- This deviceK113585 Nasal/Epistaxis PackCogent Therapeutics, LLC · 2012
- Descendant · cites it directly · 2 of its ownK141704 Novashield Injectable Nasal Packing and StentMedtronic, Inc. · 2014
- Descendant · cites it directly · 2 of its ownK122494 Posisep and Posisep X Hemostat Dressing/Intranasal SplintHemostasis, LLC · 2013
- Descendant · 2 generations on · 1 of its ownK172179 Chitogel Endoscopic Sinus Surgery KitChitogel, Ltd. · 2017
- Descendant · 3 generations on · 0 of its ownK230142 Epi-Stop Nasal Gel/epistaxis packBiomed Ent, Inc. · 2023
- Descendant · 2 generations on · 0 of its ownK181696 ChitoZolveGyrus Acmi, Inc. · 2018
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K141704Novashield Injectable Nasal Packing and StentMedtronic, Inc. · 2014 · cites it directly2descendants
- K122494Posisep and Posisep X Hemostat Dressing/Intranasal SplintHemostasis, LLC · 2013 · cites it directly2descendants
- K172179Chitogel Endoscopic Sinus Surgery KitChitogel, Ltd. · 2017 · 2 generations on1descendant
- K230142Epi-Stop Nasal Gel/epistaxis packBiomed Ent, Inc. · 2023 · 3 generations on0descendants
- K181696ChitoZolveGyrus Acmi, Inc. · 2018 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K821150 | NU-Gauze Sponge | Johnson & Johnson Professionals, Inc. | 1982 | — |
| −3 | K984069 | Entaxis Nasal Packing | Les Laboratorires Brothier, S.A. | 1999 | — |
| −2 | K993362 | Hylasine | Biomatrix, Inc. | 2000 | — |
| −1 | K043035 | Sepragel Ent Bioresorbable Packing/Stent | Genzyme Corporation | 2005 | — |
| 0 (this device) | K113585 | Nasal/Epistaxis Pack | Cogent Therapeutics, LLC | 2012 | — |
| +1 | K141704 | Novashield Injectable Nasal Packing and Stent | Medtronic, Inc. | 2014 | — |
| +1 | K122494 | Posisep and Posisep X Hemostat Dressing/Intranasal Splint | Hemostasis, LLC | 2013 | — |
| +2 | K172179 | Chitogel Endoscopic Sinus Surgery Kit | Chitogel, Ltd. | 2017 | — |
| +3 | K230142 | Epi-Stop Nasal Gel/epistaxis pack | Biomed Ent, Inc. | 2023 | — |
| +2 | K181696 | ChitoZolve | Gyrus Acmi, Inc. | 2018 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2023 | 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K052099 | Nasopore Nasal Dressing, Model Ndox-Yyy/ZZSummary page 1…ENT polymer material, and Epistaxis (packing) Ill. Predicate Devices * Nasopore manufactured by Polyganics BV (K052099) * Sepragel ENT Bioresorbable Packing/Stent manufactured by Genzyme Corporation * (1(043035) * Rhino… | 2005 |
| * | K043035 | Sepragel Ent Bioresorbable Packing/StentSummary page 1…vices * Nasopore manufactured by Polyganics BV (K052099) * Sepragel ENT Bioresorbable Packing/Stent manufactured by Genzyme Corporation * (1(043035) * Rhinocelri Nasal Packings manufactured by Boston Medical Products, Inc. (K972459) * MeroPack Bi… | 2005 |
| * | K972459 | Rhinocell Nasal PackingsSummary page 1…acking/Stent manufactured by Genzyme Corporation * (1(043035) * Rhinocelri Nasal Packings manufactured by Boston Medical Products, Inc. (K972459) * MeroPack Bioresorbable Nasal Packing and Sinus Stent manufactured by Medtronic Xomed Inc. (K04138 1)… | 1997 |
| * | K041381 | Meropack Bioresorbable Nasal Packing and Sinus StentSummary page 1…y Boston Medical Products, Inc. (K972459) * MeroPack Bioresorbable Nasal Packing and Sinus Stent manufactured by Medtronic Xomed Inc. (K04138 1) * MeroGel Control Gel ENT Surgical Dressing manufactured by Medtronic Xomed Inc. (K002972) IV. Prod… | 2004 |
| * | K002972 | Merogel Control Gel Ent Surgical DressingSummary page 1…tent manufactured by Medtronic Xomed Inc. (K04138 1) * MeroGel Control Gel ENT Surgical Dressing manufactured by Medtronic Xomed Inc. (K002972) IV. Product Description The Nasal/Epistaxis Pack is a sterile, single use, co-polymer of polyethylene glycol… | 2000 |
What descends from it? (7)
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 30 years and passes through 5 companies; a new generation was cleared every 6.8 years on median.
- None of the 17 ancestors has a recall.
- Of its descendants, K141704 (Medtronic, Inc., 2014) has gone furthest, with 2 descendants of its own.
- 9 other devices also cite its predicate K052099.
How does its category compare?
All LYA devicesLYA Splint, Intranasal Septal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 Nasal/Epistaxis Pack is a sterile, singe use device intended for use in patients undergoing nasal/sinus surgery as a space-occupying packing. The Nasat/Epistaxis Pack is indicated for use in patients undergoing nasal/sinus surgery as a space occupying packing to: * Separate tissue or structures compromised by surgical trauma;. * Separate and prevent adhesions between mucosal surfaces during mesothelial cell regeneration in the nasal cavity; * Help…
Read the full statement (117 words)
The Nasal/Epistaxis Pack is a sterile, singe use device intended for use in patients undergoing nasal/sinus surgery as a space-occupying packing.
The Nasat/Epistaxis Pack is indicated for use in patients undergoing nasal/sinus surgery as a space occupying packing to:
* Separate tissue or structures compromised by surgical trauma;.
* Separate and prevent adhesions between mucosal surfaces during mesothelial cell regeneration in the nasal cavity;
* Help control minimal bleeding following surgery or trauma;
* Help control minimal bleeding following surgery or nasal trauma by tamponade effect, blood absorption and platelet aggregation;
* Act as an adjunct to aid in the natural healing process.
The Nasal/Epistaxis Pack is indicated for use as a nasal packing to treat epistaxis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113585 · printed Nov 5, 2026
Cite this page
510(k) Report. “K113585: Nasal/Epistaxis Pack.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K113585
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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