510(k) · Cleared
ClearedNovapak Nasal Sinus Packing and Stent
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Xomed · LYA Splint, Intranasal Septal
Cleared on Dec 8, 2020 as substantially equivalent to K052099 (Polyganics B.V.,, 2005) after an 89-day review. Its family tree reaches back 3 generations to 1997.
- Decided
- Dec 8, 2020
- Review
- 89 days
- Class
- Class I
- Product code
- LYA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K972082 (1997). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK972082 Custom Nasal SplintBoston Medical Products, Inc. · 1997
- 2 generations backK012532 Sepragel SinusGenzyme Corp. · 2001
- 1 generation backK052099 Nasopore Nasal Dressing, Model Ndox-Yyy/ZZPolyganics B.V., · 2005
- This deviceK202623 Novapak Nasal Sinus Packing and StentMedtronic Xomed · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K972082 | Custom Nasal Splint | Boston Medical Products, Inc. | 1997 | — |
| −2 | K012532 | Sepragel Sinus | Genzyme Corp. | 2001 | — |
| −1 | K052099 | Nasopore Nasal Dressing, Model Ndox-Yyy/ZZ | Polyganics B.V., | 2005 | — |
| 0 (this device) | K202623 | Novapak Nasal Sinus Packing and Stent | Medtronic Xomed | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 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? (1)
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 4…anasal Splint (21 CFR 874.4780) Classification: Class I Non-exempt (21 CFR 874.4780) Product Code: LYA Predicate Device: NasoPore® K052099 Reference Devices: Posisep® K122494 Novashield™ K141704… | 2005 |
| † | K122494 | Posisep and Posisep X Hemostat Dressing/Intranasal Splint | 2013 |
| † | K141704 | Novashield Injectable Nasal Packing and Stent | 2014 |
| † | K172179 | Chitogel Endoscopic Sinus Surgery Kit | 2017 |
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 23 years and passes through 4 companies; a new generation was cleared every 4.3 years on median.
- None of the 6 ancestors has a recall.
- 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. 2020, 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 Novapak Nasal Sinus Packing and Stent is intended 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 in the nasal cavity.
• Control minimal bleeding following surgery or trauma by tamponade effect, blood absorption, and platelet aggregation.
• Act as an adjunct to aid in the natural healing process.
Novapak is indicated for use as a nasal packing to treat epistaxis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K202623 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202623: Novapak Nasal Sinus Packing and Stent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K202623
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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