# K974237: Gsi 70 Audiopath Screener

- Pathway: 510(k) (Traditional)
- Applicant: Grason-Stadler, Inc.
- Decided: Feb 10, 1998 after 90 days
- Product code: EWO (Audiometer)
- Device class: 2
- Regulation: 21 CFR 874.1050
- 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 K902540 (1990). 3 ancestors in all.
18 later devices descend from it; 2 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K934658: Gsi 60 Dpoae System, Lucas Grason-Stadler, Inc. (1994) Summary page 1.
- K911095: Gsi 37 Auto Tymp, Lucas Grason-Stadler, Inc. (1991) Summary page 1.
- K902540: Gsi 17 Screening Audiometer, Grason-Stadler, Inc. (1990) Summary page 1.

## Most influential descendants
- K982642: Echo-Screen (1998), 15 descendants of its own
- K013977: Echo-Screen T, TA, TD, Tda, TC (2002), 14 descendants of its own
- K122067: Type 1077 Accuscreen (2012), 9 descendants of its own
- K061744: Cochlea-Scan / Cochlea-Scan Plus (2006), 5 descendants of its own
- K133012: Sentiero (2014), 4 descendants of its own

## Indications for use
The Grason-Stadler Inc. model GSI 70 AudioPath™ Hearing Screener is similar to and predicated upon the Grason-Stadler Inc. model GSI 60 Otoacoustic Emissions/Screening Audiometer, the GSI 37 Auto Tymp Middle Ear Analyzer, and the GSI 17 Pure Tone Screening Audiometer. The purpose of this device is to detect as well as track hearing loss and abnormal middle ear conditions in all ages of patients (from premature infants through adults). The instrument has combined a battery of testing capabilities such as Otoacoustic Emission Screening, Tympanometry, and Pure Tone Audiometry within one hand held instrument. The device is intended to be used by trained personnel within a medical or school environment. This device is not intended for use in prescribing or fitting assistive listening devices such as hearing aids, cochlear implants or wireless microphones, or to diagnose the causes of detected hearing losses.

Source page: https://510kreport.com/device/K974237
Methodology: https://510kreport.com/methodology