# Grason-Stadler, Inc.

- Location (FDA's records): Littleton, MA
- FDA decisions: 17 (1979–2020): 17 510(k) clearances
- Names in FDA's records: Grason-Stadler, Inc. (16); Grason Stadler (1)
- Product codes: EWO (12), GWJ (2), ETY (2), ETW (1)
- Predicates its devices cite: 9 (1 its own); citations of its devices by later devices: 7 (1 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Lucas Grason-Stadler, Inc.: 3 (https://510kreport.com/company/lucas-grason-stadler)
- Intelligent Hearing Systems: 2 (https://510kreport.com/company/intelligent-hearing-systems)
- Interacoustics A/S: 2 (https://510kreport.com/company/interacoustics-a-s)
- Etymotic Research: 1 (https://510kreport.com/company/etymotic-research)

## Firms that cite its devices most
- Viasys Healthcare GmbH: 2 (https://510kreport.com/company/viasys-healthcare)
- Fischer-Zoth Audiologic Systems, Inc.: 1 (https://510kreport.com/company/fischer-zoth-audiologic-systems)
- Gn Otometrics A/S: 1 (https://510kreport.com/company/gn-otometrics-a-s)
- Intelligent Hearing Systems: 1 (https://510kreport.com/company/intelligent-hearing-systems)
- Etymotic Research: 1 (https://510kreport.com/company/etymotic-research)

## Its most-cited devices
- K902540: Gsi 17 Screening Audiometer (1990), cited by 2
- K000097: Gsi 2000 Middle Ear Analyzer (2000), cited by 2
- K974237: Gsi 70 Audiopath Screener (1998), cited by 2
- K890124: ILO88 Otodynamic Analyzer Screening Audiometer (1989), cited by 1

## Recent decisions
- K193033: GSI Audera Pro (Apr 24, 2020)
- K180287: GSI Corti (May 11, 2018)
- K172403: GSI Novus (Oct 20, 2017)
- K000097: Gsi 2000 Middle Ear Analyzer (Apr 12, 2000)
- K974237: Gsi 70 Audiopath Screener (Feb 10, 1998)
- K970324: Gsi SA60 Dpoae System (Jun 6, 1997)
- K953684: Gsi 61 Clinical Audiometer (Oct 27, 1995)
- K951759: Gsi 65 Computerized Audiometer (Jul 6, 1995)

Source page: https://510kreport.com/company/grason-stadler