510(k) · Cleared
ClearedNasopore Ear, Models ND04, ND05
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Polyganics B.V., · KCN Ear Wick
Cleared on Oct 18, 2006 as substantially equivalent to K973578 (Invotec International, Inc., 1997) and 1 other predicate after a 49-day review. Its family tree reaches back 3 generations to 1997.
- Decided
- Oct 18, 2006
- Review
- 49 days
- Class
- Class I
- Product code
- KCN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K972082 (1997). 7 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 deviceK062540 Nasopore Ear, Models ND04, ND05Polyganics B.V., · 2006
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) | K062540 | Nasopore Ear, Models ND04, ND05 | Polyganics B.V., | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 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 KCN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K973578 | Invotec Ear Tampon (Wick) W/StringSummary page 1…Ear Wick, 21 CFR 874.5220 Device Classification: Class I non exempt. Predicate - Invotec Ear Tampon (Wick) w/String; Invotec Internat.; K973578 Devices: - Nasopore® nasal dressing, Polyganics, K052099 Performance For the Nasopore® performance, the FDA,… | 1997 |
| * | K052099 | Nasopore Nasal Dressing, Model Ndox-Yyy/ZZSummary page 1…ss I non exempt. Predicate - Invotec Ear Tampon (Wick) w/String; Invotec Internat.; K973578 Devices: - Nasopore® nasal dressing, Polyganics, K052099 Performance For the Nasopore® performance, the FDA, under section 514 of the Food, Standards Drug and Cosmetic Act,… | 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 9 years and passes through 3 companies; a new generation was cleared every 4.1 years on median.
- None of the 7 ancestors has a recall.
- 1 other device also cites its predicate K973578.
How does its category compare?
All KCN devicesKCN Ear Wick: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KCN
FDA has decided no KCN device since 2007.
Median 510(k) review, days · KCN
Too few KCN 510(k)s in any year since 2007 to give a median.
Recalls per year · KCN
No recall names KCN since 2007.
Adverse event reports per year · KCN
1in 2010
MAUDE reports naming product code KCN, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Nasopore® Ear is a fragmentable ear packing and is indicated for use in
patients, undergoing ear surgery, as a space occupying stent to separate
and prevent adhesions between mucosal surfaces; to help control mini-
mal bleeding, following ear surgery, by tamponade effect and blood ab-
sorption.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062540 · printed Nov 4, 2026
Cite this page
510(k) Report. “K062540: Nasopore Ear, Models ND04, ND05.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K062540
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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