510(k) · Cleared
ClearedEustachi Ear Pressure Relief Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Exercore, LLC · MJV Device, Inflation, Middle Ear
Cleared on Feb 19, 2021 as substantially equivalent to K073401 (Micromedics, Inc., 2008) after a 58-day review. Its family tree reaches back 2 generations to 1992. 2 later devices descend from it.
- Decided
- Feb 19, 2021
- Review
- 58 days
- Class
- Class U
- Product code
- MJV
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K920840 (1992). 3 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK920840 OtoventAbigo Medical AB · 1992
- 1 generation backK073401 Earpopper, Model EP-2000, EP-2100, EP-3000Micromedics, Inc. · 2008
- This deviceK203754 Eustachi Ear Pressure Relief DeviceExercore, LLC · 2021
- Descendant · cites it directly · 1 of its ownK230502 Ear Pressure Relief Device (Model:ER813B)Ningbo Albert Novosino Co., Ltd. · 2023
- Descendant · 2 generations on · 0 of its ownK252751 Earflo (EF001)Earflo, Inc. · 2026
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K920840 | Otovent | Abigo Medical AB | 1992 | — |
| −1 | K073401 | Earpopper, Model EP-2000, EP-2100, EP-3000 | Micromedics, Inc. | 2008 | — |
| 0 (this device) | K203754 | Eustachi Ear Pressure Relief Device | Exercore, LLC | 2021 | — |
| +1 | K230502 | Ear Pressure Relief Device (Model:ER813B) | Ningbo Albert Novosino Co., Ltd. | 2023 | — |
| +2 | 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 |
|---|---|---|
| 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
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K073401 | Earpopper, Model EP-2000, EP-2100, EP-3000Summary page 4…stachi Classification Name: Middle Ear Inflation Device Regulatory Class: Unclassified Product Code: MJV III. PREDICATE DEVICE EarPopper, K073401 This predicate has not been subject to a design-related recall. No reference devices were used in this submission.… | 2008 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K230502 | Ear Pressure Relief Device (Model:ER813B) | 2023 | 1 |
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?
- The line of descent spans 29 years and passes through 3 companies; a new generation was cleared every 15.4 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K230502 (Ningbo Albert Novosino Co., Ltd., 2023) has gone furthest, with 1 descendant 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. 2021, 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 Eustachi 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 Eustachi 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K203754 · printed Nov 4, 2026
Cite this page
510(k) Report. “K203754: Eustachi Ear Pressure Relief Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K203754
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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