# K991562: Pascal Medical AB Meniett 20

- Pathway: 510(k) (Traditional)
- Applicant: Pascal Medical AB
- Decided: Dec 28, 1999 after 238 days
- Product code: ETY (Tester, Auditory Impedance)
- Device class: 2
- Regulation: 21 CFR 874.1090
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K822745 (1982). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K822745: The Screening Tympanometer, American Electromedics Corp. (1982). 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”.
- (no number) Hyper/Hypobaric pressure chambers: named in the summary without a submission number

## Indications for use
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.

Source page: https://510kreport.com/device/K991562
Methodology: https://510kreport.com/methodology