# K021895: Bio-Logic Master Evoked Response System

- Pathway: 510(k) (Special)
- Applicant: Bio-Logic Systems Corp.
- Decided: Jul 1, 2002 after 21 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.
13 later devices descend from it; 3 cite it directly.
0 of 17 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
- K070696: Interacoustics Assr, Eclipse System (Cabinet Name) (2007), 6 descendants of its own
- K133012: Sentiero (2014), 4 descendants of its own
- K031051: Smartep-Assr, Model M811007 (2004), 3 descendants of its own
- K171038: Hearing Healthcare Pro (2017), 1 descendant of its own
- K073626: Bio-Logic Master II Evoked Response System (2008), 1 descendant 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, MASTER, like its predicate device, the Navigator Fro, is a diagnostic device intended to be used as part of a set of audiometric test protocols. 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. It allows for the estimation of behavioral hearing threshold at various frequencies, through the use of ABR (Auditory Brainstem Response) or ASSR (Auditory Steady-state Response) test protocols. It is designed to be used as a diagnostic test procedure by individuals who are trained in the performance and interpretation of evoked potentials such as audiologists and physicians. The results of the test will be used by trained hearing health care professionals to make recommendations regarding appropriate intervention strategies. Bio-logic EP Systems can be used for patients of all ages, from children to adults, including infants and geriatric patients. 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/K021895
Methodology: https://510kreport.com/methodology