510(k) · Cleared
Recalled · Class II · 2022Ultracell Ear Wick
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ultracell Medical Technologies, Inc. · KCN Ear Wick
Cleared on Feb 1, 1993 after a 371-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. It has been recalled 6 times.
- Decided
- Feb 1, 1993
- Review
- 371 days
- Class
- Class I
- Product code
- KCN
- Recalls
- 6
- Predicates
- 0
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
Sources: FDA 510(k) database (decision fields), 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 25, 2022 | Class II | Z-1625-2022 | Environmental control | Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21. |
| Jan 8, 2003 | Not classified | Z-0480-03 | Other | Sterility of the device is compromised |
| Jan 8, 2003 | Not classified | Z-0481-03 | Other | Sterility of the device is compromised |
| Jan 8, 2003 | Not classified | Z-0482-03 | Other | Sterility of the device is compromised |
| Jan 8, 2003 | Not classified | Z-0483-03 | Other | Sterility of the device is compromised |
| Jan 8, 2003 | Not classified | Z-0485-03 | Other | Sterility of the device is compromised |
The 5 latest of 6 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
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 | — |
https://510kreport.com/device/K920357 · printed Nov 4, 2026
Cite this page
510(k) Report. “K920357: Ultracell Ear Wick.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K920357
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026