510(k) · Cleared
ClearedInvotec Ear Tampon (Wick) W/String
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Invotec International, Inc. · KCN Ear Wick
Cleared on Nov 6, 1997 after a 48-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 3 later devices descend from it.
- Decided
- Nov 6, 1997
- Review
- 48 days
- Class
- Class I
- Product code
- KCN
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK973578 Invotec Ear Tampon (Wick) W/StringInvotec International, Inc. · 1997
- Descendant · cites it directly · 1 of its ownK070715 Nasopore EarPolyganics B.V., · 2007 · Recalled
- Descendant · 2 generations on · 0 of its ownK210411 PosiSep EAR Fragmentable Ear DressingHemostasis, LLC · 2022
- Descendant · cites it directly · 0 of its ownK062540 Nasopore Ear, Models ND04, ND05Polyganics B.V., · 2006
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K973578 | Invotec Ear Tampon (Wick) W/String | Invotec International, Inc. | 1997 | — |
| +1 | K070715 | Nasopore Ear | Polyganics B.V., | 2007 | 13 |
| +2 | K210411 | PosiSep EAR Fragmentable Ear Dressing | Hemostasis, LLC | 2022 | — |
| +1 | K062540 | Nasopore Ear, Models ND04, ND05 | Polyganics B.V., | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2022 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K070715 (Polyganics B.V.,, 2007) has gone furthest, with 1 descendant of its own.
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?
The Invotec Ear Tampon (wick) w/ string, is indicated for use as a ear packing for use after internal ear surgery. The packing is to be used in the ear canal as a surgical packing.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K973578 · printed Nov 4, 2026
Cite this page
510(k) Report. “K973578: Invotec Ear Tampon (Wick) W/String.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K973578
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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