510(k) · Cleared
ClearedPascal Medical AB Meniett 20
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pascal Medical AB · ETY Tester, Auditory Impedance
Cleared on Dec 28, 1999 as substantially equivalent to K822745 (American Electromedics Corp., 1982) after a 238-day review. Its family tree reaches back 1 generation to 1982.
- Decided
- Dec 28, 1999
- Review
- 238 days
- Class
- Class II
- Product code
- ETY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K822745 (1982). No later device cites it as a predicate yet.
- Root · 1 generation backK822745 The Screening TympanometerAmerican Electromedics Corp. · 1982
- This deviceK991562 Pascal Medical AB Meniett 20Pascal Medical AB · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K822745 | The Screening Tympanometer | American Electromedics Corp. | 1982 | — |
| 0 (this device) | K991562 | Pascal Medical AB Meniett 20 | Pascal Medical AB | 1999 | — |
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 ETY? 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? (2)
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 |
|---|---|---|---|
| * | K822745 | The Screening Tympanometer Our OCR of the scanned summary read K822475, FDA’s number for Total Protein Standard, #65074 (Emd Chemicals, Inc.). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “American Electromedics Corporation Screening Tympanometer”. | 1982 |
| * | — | Hyper/Hypobaric pressure chambers Named without a submission number |
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?
- Its one ancestor has no recall.
How does its category compare?
All ETY devicesETY Tester, Auditory Impedance: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · ETY
1in 2019
2026 to Oct 25, outlined.
Median 510(k) review, days · ETY
Too few ETY 510(k)s in any year since 2007 to give a median.
Recalls per year · ETY
No recall names ETY since 2007.
Adverse event reports per year · ETY
1in 2025
MAUDE reports naming product code ETY, 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 | 1 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 2 | — | 0 | 0 |
| 2016 | 2 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Meniett 20 is indicated for symptomatic treatment of Meniére’s disease. The therapeutic effect of Meniett 20 is achieved by applying low frequency, low amplitude pressure pulses to the middle ear whereby inner ear endolymphatic fluids are assumed to be evacuated from the cochlea and thus relieve the patient of the symptoms associated with endolymphatic hydrops.
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/K991562 · printed Nov 5, 2026
Cite this page
510(k) Report. “K991562: Pascal Medical AB Meniett 20.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K991562
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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