510(k) · Cleared
ClearedNasopore-FD
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 Aug 7, 2014 as substantially equivalent to K052099 (Polyganics B.V.,, 2005) after a 69-day review. Its family tree reaches back 3 generations to 1997.
- Decided
- Aug 7, 2014
- Review
- 69 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.
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) | K141423 | Nasopore-FD | Polyganics B.V., | 2014 | — |
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…Product code: LYA ___________________________________________________________________________ Predicate Device: Nasopore Polyganics BV K052099 ______________________________________________________________________________ Performance For the performance of in… | 2005 |
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 17 years and passes through 3 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. 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?
NASOPORE® FD 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/K141423 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141423: Nasopore-FD.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141423
Report an extraction error
Are you the manufacturer?
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