510(k) · Cleared
ClearedEarflo (EF001)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Earflo, Inc. · MJV Device, Inflation, Middle Ear
Cleared on Feb 10, 2026 as substantially equivalent to K230502 (Ningbo Albert Novosino Co., Ltd., 2023) after a 165-day review. Its family tree reaches back 4 generations to 1992.
- Decided
- Feb 10, 2026
- Review
- 165 days
- Class
- Class U
- Product code
- MJV
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K920840 (1992). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK920840 OtoventAbigo Medical AB · 1992
- 3 generations backK073401 Earpopper, Model EP-2000, EP-2100, EP-3000Micromedics, Inc. · 2008
- 2 generations backK203754 Eustachi Ear Pressure Relief DeviceExercore, LLC · 2021
- 1 generation backK230502 Ear Pressure Relief Device (Model:ER813B)Ningbo Albert Novosino Co., Ltd. · 2023
- This deviceK252751 Earflo (EF001)Earflo, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K920840 | Otovent | Abigo Medical AB | 1992 | — |
| −3 | K073401 | Earpopper, Model EP-2000, EP-2100, EP-3000 | Micromedics, Inc. | 2008 | — |
| −2 | K203754 | Eustachi Ear Pressure Relief Device | Exercore, LLC | 2021 | — |
| −1 | K230502 | Ear Pressure Relief Device (Model:ER813B) | Ningbo Albert Novosino Co., Ltd. | 2023 | — |
| 0 (this device) | K252751 | Earflo (EF001) | Earflo, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 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 K230502 Ear Pressure Relief Device (Model:ER813B)score 9.1 · 3 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 |
|---|---|---|---|
| * | K230502 | Ear Pressure Relief Device (Model:ER813B)Summary page 5…), Division of Dental and ENT Devices (DHT1B); Ear Nose & Throat Panel Primary Predicate Device: Ear Pressure Relief Device, K230502, Code MJV Reference Device: Eustachi Ear Pressure Relief Device, K203754, Code MJV A. Device Description Ea… | 2023 |
| † | K203754 | Eustachi Ear Pressure Relief Device | 2021 |
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.
What does this lineage say?
- The line of descent spans 34 years and passes through 5 companies; a new generation was cleared every 12.9 years on median.
- None of the 5 ancestors has a recall.
How does its category compare?
All MJV devicesMJV Device, Inflation, Middle Ear: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 Earflo 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 Earflo 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/K252751 · printed Nov 6, 2026
Cite this page
510(k) Report. “K252751: Earflo (EF001).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K252751
Report an extraction error
Are you the manufacturer?
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