510(k) · Cleared
ClearedAdult Silicone Ear Plugs, Models # 68053, 68057
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Apothecary Products, Inc. · EWD Protector, Hearing (Insert)
Cleared on Jun 25, 2002 after a 148-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Jun 25, 2002
- Review
- 148 days
- Class
- Class U
- Product code
- EWD
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
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 EWD? 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?
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.
How does its category compare?
All EWD devicesEWD Protector, Hearing (Insert): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EWD
FDA has decided no EWD device since 2007.
Median 510(k) review, days · EWD
Too few EWD 510(k)s in any year since 2007 to give a median.
Recalls per year · EWD
No recall names EWD since 2007.
Adverse event reports per year · EWD
2in 2024
MAUDE reports naming product code EWD, 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 | 2 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 2 |
| 2012 | 0 | — | 0 | 4 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 4 |
| 2019 | 0 | — | 0 | 3 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Adult Silicone Ear Plugs are used for protection from noise. This device is for adult use only.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K020296 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020296: Adult Silicone Ear Plugs, Models # 68053, 68057.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020296
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026