# K021801: Bio-Logic Abaer Cub with Integrated Oae & Abr Functions

- Pathway: 510(k) (Special)
- Applicant: Bio-Logic Systems Corp.
- Decided: Jun 27, 2002 after 24 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: 4 generations back to K930328 (1993). 5 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974076: Sport/Audx Oae Test Instrument with Bio-Logic Ear Probe, Bio-Logic Systems Corp. (1998) Summary page 1.
- K021215: Bio-Logic Abaer Cub, Bio-Logic Systems Corp. (2002)

## Most influential descendants
- 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 Otoacoustic Emissions (OAE) and Evoked Potential (EP) product families are 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 with Automated OAE and ABR, like it’s predicate devices, the AuDX and the ABaer Cub, is especially indicated for use in the screening of infants to determine hearing loss. The Bio-logic OAE and EP Systems 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 OAE and EP families 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/K021801
Methodology: https://510kreport.com/methodology