# K021215: Bio-Logic Abaer Cub

- Pathway: 510(k) (Special)
- Applicant: Bio-Logic Systems Corp.
- Decided: May 15, 2002 after 28 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: 3 generations back to K930328 (1993). 3 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K994149: Modification to Bio-Logic Evoked Potential for Abaer/ Navigator Pro., Bio-Logic Systems Corp. (1999) Summary page 1.

## Most influential descendants
- K021801: Bio-Logic Abaer Cub with Integrated Oae & Abr Functions (2002), 4 descendants of its own
- K112247: A Baer with Abaer I/O Function (2012), 1 descendant of its own
- K111618: Audx Otoacoustic Emissions Measurement System with Audx I/O Function (2011), 1 descendant of its own
- K122496: Audx Pro Otoacoustic Emissions Measurement System (2012), 0 descendants of its own
- K090579: Smartscreener-PLUS2 (2009), 0 descendants of its own

## Indications for use
The Bio-logic Evoked Potential (EP) product family is indicated for use in the recording and analysis of human physiological data necessary for the diagnosis of auditory and hearing-related disorders. This product, the ABaer Cub, like it’s predicate device, the ABaer, is especially indicated for use in the screening of infants to determine hearing loss. The Bio-logic EP System 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 use of the Bio-logic EP family of products is to be performed under the prescription and supervision of a physician or other trained health care professional.

Source page: https://510kreport.com/device/K021215
Methodology: https://510kreport.com/methodology