# K090579: Smartscreener-PLUS2

- Pathway: 510(k) (Traditional)
- Applicant: Intelligent Hearing Systems
- Decided: Jul 7, 2009 after 126 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: 5 generations back to K930328 (1993). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021801: Bio-Logic Abaer Cub with Integrated Oae & Abr Functions, Bio-Logic Systems Corp. (2002) Summary page 1.
- K031051: Smartep-Assr, Model M811007, Intelligent Hearing Systems (2004)

## Indications for use
The SmartScreener-Plus2 device is indicated for use in the recording and automated analysis of human physiological data (auditory brainstem responses and/or otoacoustic emissions) necessary for the diagnosis of auditory and hearing-related disorders. The device is especially indicated for use in the screening of infants to determine hearing loss. Sites appropriate for use include the well-baby nursery, neonatal intensive care unit (NICU), mother's bedside, outpatient clinic, audiologist's office, or doctor's office. The device is simple to operate. It does not require special technical skills or interpretation of results by the device operator. Basic training with the device is sufficient to learn how to operate it. The SmartScreener-Plus2 device can be used for patients of all ages, from children to adults, including infants and geriatric patients. It is especially indicated for use in testing individuals for whom behavioral audiometric results are deemed unreliable, such as infants, young children,' and Cognitively impaired or uncooperative adults. The possible anatomical sites of contact are the patient's ear, ear canal, and/or external skin surrounding the ear (with the contact object being a sound delivery eartip, headphone cushion, or an acoustic ear coupler such as a circumaural ear cup, intra-aural ear bud, or supra-aural ear patch), the patient's head (with the contact object being a bone vibrator), and the patient's head, nape of the neck and shoulder (with the contact object being electrodes that are capable of measuring biopotentials). The SmartScreener-Plus2 device is for prescription use.

Source page: https://510kreport.com/device/K090579
Methodology: https://510kreport.com/methodology