510(k) · Cleared
ClearedEarclear
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arisil Medical · MJV Device, Inflation, Middle Ear
Cleared on May 24, 1995 after a 47-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.
- Decided
- May 24, 1995
- Review
- 47 days
- Class
- Class U
- Product code
- MJV
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 1 citing it directly.
- This deviceK951596 EarclearArisil Medical · 1995
- Descendant · cites it directly · 3 of its ownK073401 Earpopper, Model EP-2000, EP-2100, EP-3000Micromedics, Inc. · 2008
- Descendant · 2 generations on · 2 of its ownK203754 Eustachi Ear Pressure Relief DeviceExercore, LLC · 2021
- Descendant · 3 generations on · 1 of its ownK230502 Ear Pressure Relief Device (Model:ER813B)Ningbo Albert Novosino Co., Ltd. · 2023
- Descendant · 4 generations on · 0 of its ownK252751 Earflo (EF001)Earflo, Inc. · 2026
Most influential descendants
Showing 4 of 4 · See all- K073401Earpopper, Model EP-2000, EP-2100, EP-3000Micromedics, Inc. · 2008 · cites it directly3descendants
- K203754Eustachi Ear Pressure Relief DeviceExercore, LLC · 2021 · 2 generations on2descendants
- K230502Ear Pressure Relief Device (Model:ER813B)Ningbo Albert Novosino Co., Ltd. · 2023 · 3 generations on1descendant
- K252751Earflo (EF001)Earflo, Inc. · 2026 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K951596 | Earclear | Arisil Medical | 1995 | — |
| +1 | K073401 | Earpopper, Model EP-2000, EP-2100, EP-3000 | Micromedics, Inc. | 2008 | — |
| +2 | K203754 | Eustachi Ear Pressure Relief Device | Exercore, LLC | 2021 | — |
| +3 | K230502 | Ear Pressure Relief Device (Model:ER813B) | Ningbo Albert Novosino Co., Ltd. | 2023 | — |
| +4 | K252751 | Earflo (EF001) | Earflo, Inc. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2026 | 1 | 0 |
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 MJV? 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 MJV device
- #1 K252751 Earflo (EF001)score 11.7 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K073401 | Earpopper, Model EP-2000, EP-2100, EP-3000 | 2008 | 3 |
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, K073401 (Micromedics, Inc., 2008) has gone furthest, with 3 descendants of its own.
How does its category compare?
All MJV devicesMJV Device, Inflation, Middle Ear: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MJV
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · MJV
Too few MJV 510(k)s in any year since 2007 to give a median.
Recalls per year · MJV
No recall names MJV since 2007.
Adverse event reports per year · MJV
1in 2021
MAUDE reports naming product code MJV, 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 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
https://510kreport.com/device/K951596 · printed Nov 6, 2026
Cite this page
510(k) Report. “K951596: Earclear.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K951596
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026