# K000097: Gsi 2000 Middle Ear Analyzer

- Pathway: 510(k) (Abbreviated)
- Applicant: Grason-Stadler, Inc.
- Decided: Apr 12, 2000 after 90 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
No predicates in its family tree.
5 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K033645: Otoflex 100 Tye 1012 (2004), 3 descendants of its own
- K061104: Speechlink 100 Type 1053 (2006), 1 descendant of its own
- K161707: Madsen Zodiac (2016), 0 descendants of its own
- K112733: ER35 Ero-Scan Pro Hearing Test System (2011), 0 descendants of its own
- K110286: GN Otometrics Type 1053 Freefit (2011), 0 descendants of its own

Source page: https://510kreport.com/device/K000097
Methodology: https://510kreport.com/methodology