510(k) · Cleared
ClearedEarpopper, Model EP-2000, EP-2100, EP-3000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Micromedics, Inc. · MJV Device, Inflation, Middle Ear
Cleared on Mar 14, 2008 as substantially equivalent to K951596 (Arisil Medical, 1995) and 1 other predicate after a 101-day review. Its family tree reaches back 1 generation to 1992. 3 later devices descend from it.
- Decided
- Mar 14, 2008
- Review
- 101 days
- Class
- Class U
- Product code
- MJV
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K920840 (1992). 2 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK920840 OtoventAbigo Medical AB · 1992
- This deviceK073401 Earpopper, Model EP-2000, EP-2100, EP-3000Micromedics, Inc. · 2008
- Descendant · cites it directly · 2 of its ownK203754 Eustachi Ear Pressure Relief DeviceExercore, LLC · 2021
- Descendant · 2 generations on · 1 of its ownK230502 Ear Pressure Relief Device (Model:ER813B)Ningbo Albert Novosino Co., Ltd. · 2023
- Descendant · 3 generations on · 0 of its ownK252751 Earflo (EF001)Earflo, Inc. · 2026
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 |
|---|---|---|---|---|---|
| −1 | K920840 | Otovent | Abigo Medical AB | 1992 | — |
| 0 (this device) | K073401 | Earpopper, Model EP-2000, EP-2100, EP-3000 | Micromedics, Inc. | 2008 | — |
| +1 | K203754 | Eustachi Ear Pressure Relief Device | Exercore, LLC | 2021 | — |
| +2 | K230502 | Ear Pressure Relief Device (Model:ER813B) | Ningbo Albert Novosino Co., Ltd. | 2023 | — |
| +3 | K252751 | Earflo (EF001) | Earflo, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2026 | 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 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? (3)
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 |
|---|---|---|---|
| * | K951596 | EarclearSummary page 1…n the nose and the eustachian tube. Equalizing the pressure can prevent the accumulation offluid andprevent hearingloss. SUBSTANTIALLY EQUIVALENT TO: Earclear (K951596) Arisil Medicall Otovent (K920840) ABIGO Medical Co. Politzer Bag Page… | 1995 |
| * | K920840 | OtoventSummary page 1…izing the pressure can prevent the accumulation offluid andprevent hearingloss. SUBSTANTIALLY EQUIVALENT TO: Earclear (K951596) Arisil Medicall Otovent (K920840) ABIGO Medical Co. Politzer Bag Page 5-1 SUMMARY… | 1992 |
| * | — | Politzer Bag Named without a submission number |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K203754 | Eustachi Ear Pressure Relief Device | 2021 | 2 |
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?
- None of the 2 ancestors has a recall.
- Of its descendants, K203754 (Exercore, LLC, 2021) has gone furthest, with 2 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. 2008, this device’s year, is highlighted.
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 | — |
What is it indicated for?
The EarPopper is indicated for the treatment of negative middle ear pressure. Negative middle ear pressure can lead to fluid accumulation in the middle ear, impaired hearing and hearing loss. The EarPopper provides a method of ventilating the middle ear by momentarily increasing the air pressure in the nose and the eustachian tube. Equalizing the pressure can prevent the accumulation of fluid and prevent hearing loss.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073401 · printed Nov 4, 2026
Cite this page
510(k) Report. “K073401: Earpopper, Model EP-2000, EP-2100, EP-3000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073401
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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