510(k) · Cleared
ClearedNasopore Nasal Dressing, Model Ndox-Yyy/ZZ
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Polyganics B.V., · LYA Splint, Intranasal Septal
Cleared on Nov 21, 2005 as substantially equivalent to K012532 (Genzyme Corp., 2001) and 2 other predicates after a 110-day review. Its family tree reaches back 2 generations to 1997. 17 later devices descend from it.
- Decided
- Nov 21, 2005
- Review
- 110 days
- Class
- Class I
- Product code
- LYA
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K972082 (1997). 5 ancestors in all. 17 later devices descend from it, 10 citing it directly.
- Root · 2 generations backK972082 Custom Nasal SplintBoston Medical Products, Inc. · 1997
- 1 generation backK012532 Sepragel SinusGenzyme Corp. · 2001
- This deviceK052099 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 · 3 of its ownK082276 Synthemed DeviceSynthemed, Inc. · 2008
- Descendant · 2 generations on · 2 of its ownK141704 Novashield Injectable Nasal Packing and StentMedtronic, Inc. · 2014
- Descendant · 2 generations on · 2 of its ownK122494 Posisep and Posisep X Hemostat Dressing/Intranasal SplintHemostasis, LLC · 2013
- Descendant · 3 generations on · 1 of its ownK172179 Chitogel Endoscopic Sinus Surgery KitChitogel, Ltd. · 2017
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K113585Nasal/Epistaxis PackCogent Therapeutics, LLC · 2012 · cites it directly7descendants
- K082276Synthemed DeviceSynthemed, Inc. · 2008 · cites it directly3descendants
- K141704Novashield Injectable Nasal Packing and StentMedtronic, Inc. · 2014 · 2 generations on2descendants
- K122494Posisep and Posisep X Hemostat Dressing/Intranasal SplintHemostasis, LLC · 2013 · 2 generations on2descendants
- K172179Chitogel Endoscopic Sinus Surgery KitChitogel, Ltd. · 2017 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K972082 | Custom Nasal Splint | Boston Medical Products, Inc. | 1997 | — |
| −1 | K012532 | Sepragel Sinus | Genzyme Corp. | 2001 | — |
| 0 (this device) | K052099 | Nasopore Nasal Dressing, Model Ndox-Yyy/ZZ | Polyganics B.V., | 2005 | — |
| +1 | K113585 | Nasal/Epistaxis Pack | Cogent Therapeutics, LLC | 2012 | — |
| +1 | K082276 | Synthemed Device | Synthemed, Inc. | 2008 | — |
| +2 | K141704 | Novashield Injectable Nasal Packing and Stent | Medtronic, Inc. | 2014 | — |
| +2 | K122494 | Posisep and Posisep X Hemostat Dressing/Intranasal Splint | Hemostasis, LLC | 2013 | — |
| +3 | K172179 | Chitogel Endoscopic Sinus Surgery Kit | Chitogel, Ltd. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 4 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 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? (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 |
|---|---|---|---|
| * | K012532 | Sepragel SinusSummary page 1…lassification Name: Intranasal Splint, 21 CFR 874.4780 Device Classification: Class I Predicate - Seprapack/Sepragel; Genzyme; K01 2532 Devices: - Merogel Tm nasal dressing; Xomed; K982731 - MeropackTm nasal dressing… | 2001 |
| * | K982731 | Merogel Nasal Dressing and Sinus StentSummary page 1…Device Classification: Class I Predicate - Seprapack/Sepragel; Genzyme; K01 2532 Devices: - Merogel Tm nasal dressing; Xomed; K982731 - MeropackTm nasal dressing; Medtronic Xomned; K041381 Performance For the Nasopore perfo… | 1999 |
| * | K041381 | Meropack Bioresorbable Nasal Packing and Sinus StentSummary page 1…l; Genzyme; K01 2532 Devices: - Merogel Tm nasal dressing; Xomed; K982731 - MeropackTm nasal dressing; Medtronic Xomned; K041381 Performance For the Nasopore performance, the FDA, under section 514 of the Food, Drug Standards and Cosmet… | 2004 |
What descends from it? (17)
See all 1710 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K113585 | Nasal/Epistaxis Pack | 2012 | 7 |
| K082276 | Synthemed Device | 2008 | 3 |
| K092401 | Sinexus Sinus Stent Gen 2, Model 1999-25 | 2009 | 1 |
| K070715 | Nasopore Ear | 2007 | 1 |
| K202623 | Novapak Nasal Sinus Packing and Stent | 2020 | 0 |
| K160101 | SinuBand | 2016 | 0 |
| K141816 | Hemopore | 2014 | 0 |
| K141423 | Nasopore-FD | 2014 | 0 |
| K140992 | Arthrocare Nasastent CMC Nasal Dressing | 2014 | 0 |
| K062540 | Nasopore Ear, Models ND04, ND05 | 2006 | 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 8 years and passes through 3 companies; a new generation was cleared every 4.3 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K113585 (Cogent Therapeutics, LLC, 2012) has gone furthest, with 7 descendants of its own.
- 5 other devices also cite its predicate K012532.
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?
Nasopore® nasal dressing is a fragmentable nasal dressing and is indicated for use in patients undergoing nasal/sinus surgery as a space occupying stent to separate and prevent adhesions between mucosal surfaces; to help control minimal bleeding following surgery or nasal trauma by tamponade effect and blood absorption.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052099 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052099: Nasopore Nasal Dressing, Model Ndox-Yyy/ZZ.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052099
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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