# K122067: Type 1077 Accuscreen

- Pathway: 510(k) (Traditional)
- Applicant: Gn Otometrics
- Decided: Sep 27, 2012 after 73 days
- Product code: GWJ (Stimulator, Auditory, Evoked Response)
- Device class: 2
- Regulation: 21 CFR 882.1900
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K902540 (1990). 11 ancestors in all.
9 later devices descend from it; 2 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013977: Echo-Screen T, TA, TD, Tda, TC, Fischer-Zoth Audiologic Systems, Inc. (2002) Summary page 1.

## Most influential descendants
- K133012: Sentiero (2014), 4 descendants of its own
- K132957: Madsen Accuscreen Type 1077 (2014), 3 descendants of its own
- K143395: Otoport OAE +ABR Advance, Otoport OAE+ABR DP+TE, Otoport OAE+ABR Screener-Otocheck OAE+ABR, Otocheck OAE+ABR LE, Otocheck ABR Screener-Otodynamics ABR Upgrade Kit (2015), 2 descendants of its own
- K171038: Hearing Healthcare Pro (2017), 1 descendant of its own
- K234095: OtoNova/OtoNova Pro (2024), 0 descendants of its own

## Indications for use
AccuScreen is a portable instrument used to screen infants for hearing loss. The instrument uses the Distortion Product Otoacoustic Emissions (DPOAE), Transient Evoked Otoacoustic Emissions (TEOAE) and Auditory Brainstemn Response (ABR) technologies. The instrument'is intended for screening infants from 34 weeks (gestational age) up to 6 months of age that are well enough to be ready for discharge from the hospital. Infants should be asleep or in a quiet state at the time of screening. AccuScreen is intended for use by audiologists, ENTs and other health care professionals.

Source page: https://510kreport.com/device/K122067
Methodology: https://510kreport.com/methodology