510(k) · Cleared
ClearedMeropack Bioresorbable Nasal Packing and Sinus Stent
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Xomed, Inc. · LYA Splint, Intranasal Septal
Cleared on Sep 10, 2004 after a 108-day review. The FDA summary names its predicate without a number. 25 later devices descend from it.
- Decided
- Sep 10, 2004
- Review
- 108 days
- Class
- Class I
- Product code
- LYA
- Recalls
- None
- Predicates
- 0
25 later devices descend from it, 8 citing it directly.
- This deviceK041381 Meropack Bioresorbable Nasal Packing and Sinus StentMedtronic Xomed, Inc. · 2004
- Descendant · cites it directly · 17 of its ownK052099 Nasopore Nasal Dressing, Model Ndox-Yyy/ZZPolyganics B.V., · 2005
- Descendant · cites it directly · 7 of its ownK113585 Nasal/Epistaxis PackCogent Therapeutics, LLC · 2012
- Descendant · cites it directly · 4 of its ownK063308 Advacoat Sinus Gel, Model 9100, Adva Sinus Stent, Model 9200Carbylan Biosurgery · 2006
- Descendant · cites it directly · 3 of its ownK082276 Synthemed DeviceSynthemed, Inc. · 2008
- Descendant · cites it directly · 3 of its ownK070496 Advacoat Sinus Gel and StentCarbylan Biosurgery · 2007
Showing 5 of 25 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 25 · See all- K052099Nasopore Nasal Dressing, Model Ndox-Yyy/ZZPolyganics B.V., · 2005 · cites it directly17descendants
- K113585Nasal/Epistaxis PackCogent Therapeutics, LLC · 2012 · cites it directly7descendants
- K063308Advacoat Sinus Gel, Model 9100, Adva Sinus Stent, Model 9200Carbylan Biosurgery · 2006 · cites it directly4descendants
- K082276Synthemed DeviceSynthemed, Inc. · 2008 · cites it directly3descendants
- K070496Advacoat Sinus Gel and StentCarbylan Biosurgery · 2007 · cites it directly3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K041381 | Meropack Bioresorbable Nasal Packing and Sinus Stent | Medtronic Xomed, Inc. | 2004 | — |
| +1 | K052099 | Nasopore Nasal Dressing, Model Ndox-Yyy/ZZ | Polyganics B.V., | 2005 | — |
| +1 | K113585 | Nasal/Epistaxis Pack | Cogent Therapeutics, LLC | 2012 | — |
| +1 | K063308 | Advacoat Sinus Gel, Model 9100, Adva Sinus Stent, Model 9200 | Carbylan Biosurgery | 2006 | — |
| +1 | K082276 | Synthemed Device | Synthemed, Inc. | 2008 | — |
| +1 | K070496 | Advacoat Sinus Gel and Stent | Carbylan Biosurgery | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 2 | 0 |
| 2006 | 3 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 4 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 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? (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 |
|---|---|---|---|
| * | — | MeroGel™ Nasal Dressing and Sinus Stent Named without a submission number | |
| * | — | Seprapack/Sepragel (Genzyme) Named without a submission number |
What descends from it? (25)
See all 258 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K052099 | Nasopore Nasal Dressing, Model Ndox-Yyy/ZZ | 2005 | 17 |
| K113585 | Nasal/Epistaxis Pack | 2012 | 7 |
| K063308 | Advacoat Sinus Gel, Model 9100, Adva Sinus Stent, Model 9200 | 2006 | 4 |
| K082276 | Synthemed Device | 2008 | 3 |
| K070496 | Advacoat Sinus Gel and Stent | 2007 | 3 |
| K122494 | Posisep and Posisep X Hemostat Dressing/Intranasal Splint | 2013 | 2 |
| K051911 | Gelita-Spon | 2005 | 2 |
| K130354 | Medient Middle Turbinate Implant; (Single Pack-1 Pair, Four Pack-4 Pair) | 2013 | 1 |
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, K052099 (Polyganics B.V.,, 2005) has gone furthest, with 17 descendants of its own.
How does its category compare?
All LYA devicesLYA Splint, Intranasal Septal: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
MeroPackTM Bioresorbable Nasal Dressing and Sinus Stent is indicated for use in patients undergoing nasal/sinus surgery as a space occupying stent to separate and prevent adhesions between mucosal surfaces during mesothelial cell regeneration in the nasal cavity; to help control minimal bleeding following surgery or nasal trauma by tamponade effect, blood absorption and platelet aggregation; and to prevent lateralization of the middle turbinate during the postoperative period.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041381 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041381: Meropack Bioresorbable Nasal Packing and Sinus Stent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041381
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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