510(k) · Cleared
ClearedBio-Logic Abaer Cub with Integrated Oae & Abr Functions
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio-Logic Systems Corp. · EWO Audiometer
Cleared on Jun 27, 2002 as substantially equivalent to K974076 (Bio-Logic Systems Corp., 1998) and 1 other predicate after a 24-day review. Its family tree reaches back 4 generations to 1993. 4 later devices descend from it.
- Decided
- Jun 27, 2002
- Review
- 24 days
- Class
- Class II
- Product code
- EWO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K930328 (1993). 5 ancestors in all. 4 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK930328 Navigator & Traveler Evoked Postential ProductBio-Logic Systems Corp. · 1993
- 3 generations backK992807 Bio-Logic Evoked Potential for Abaer IBio-Logic Systems Corp. · 1999
- 2 generations backK994149 Modification to Bio-Logic Evoked Potential for Abaer/ Navigator Pro.Bio-Logic Systems Corp. · 1999
- 1 generation backK021215 Bio-Logic Abaer CubBio-Logic Systems Corp. · 2002
- This deviceK021801 Bio-Logic Abaer Cub with Integrated Oae & Abr FunctionsBio-Logic Systems Corp. · 2002
- Descendant · cites it directly · 1 of its ownK112247 A Baer with Abaer I/O FunctionNatus Medical Incorporated · 2012
- Descendant · cites it directly · 1 of its ownK111618 Audx Otoacoustic Emissions Measurement System with Audx I/O FunctionNatus Medical Incorporated · 2011
- Descendant · 2 generations on · 0 of its ownK122496 Audx Pro Otoacoustic Emissions Measurement SystemBio-Logic Systems Corp. · 2012
- Descendant · cites it directly · 0 of its ownK090579 Smartscreener-PLUS2Intelligent Hearing Systems · 2009
Most influential descendants
Showing 4 of 4 · See all- K112247A Baer with Abaer I/O FunctionNatus Medical Incorporated · 2012 · cites it directly1descendant
- K111618Audx Otoacoustic Emissions Measurement System with Audx I/O FunctionNatus Medical Incorporated · 2011 · cites it directly1descendant
- K122496Audx Pro Otoacoustic Emissions Measurement SystemBio-Logic Systems Corp. · 2012 · 2 generations on0descendants
- K090579Smartscreener-PLUS2Intelligent Hearing Systems · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K930328 | Navigator & Traveler Evoked Postential Product | Bio-Logic Systems Corp. | 1993 | — |
| −3 | K992807 | Bio-Logic Evoked Potential for Abaer I | Bio-Logic Systems Corp. | 1999 | — |
| −2 | K994149 | Modification to Bio-Logic Evoked Potential for Abaer/ Navigator Pro. | Bio-Logic Systems Corp. | 1999 | — |
| −1 | K021215 | Bio-Logic Abaer Cub | Bio-Logic Systems Corp. | 2002 | — |
| 0 (this device) | K021801 | Bio-Logic Abaer Cub with Integrated Oae & Abr Functions | Bio-Logic Systems Corp. | 2002 | — |
| +1 | K112247 | A Baer with Abaer I/O Function | Natus Medical Incorporated | 2012 | — |
| +1 | K111618 | Audx Otoacoustic Emissions Measurement System with Audx I/O Function | Natus Medical Incorporated | 2011 | — |
| +2 | K122496 | Audx Pro Otoacoustic Emissions Measurement System | Bio-Logic Systems Corp. | 2012 | — |
| +1 | K090579 | Smartscreener-PLUS2 | Intelligent Hearing Systems | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in EWO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new EWO device
- #1 K234095 OtoNova/OtoNova Proscore 9.3 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K974076 | Sport/Audx Oae Test Instrument with Bio-Logic Ear ProbeSummary page 1…em (reference 21CFR 882.1900). PREDICATE DEVICE: The OAE function is substantially equivalent to the Sport/AuDX predicate device ( 5 10(k) #K974076) and the ABR function is substantially equivalent to the ABaer Cub predicate device (5 10(k)… | 1998 |
| * | K021215 | Bio-Logic Abaer Cub | 2002 |
What descends from it? (4)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 9 years and passes through 1 company; a new generation was cleared every 2.4 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K112247 (Natus Medical Incorporated, 2012) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K974076.
How does its category compare?
All EWO devicesEWO Audiometer: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EWO
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · EWO
173in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EWO
4in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EWO
13in 2025
MAUDE reports naming product code EWO, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 5 | 69 | 0 | 1 |
| 2008 | 1 | — | 1 | 1 |
| 2009 | 2 | — | 0 | 1 |
| 2010 | 2 | — | 0 | 4 |
| 2011 | 3 | 151 | 0 | 2 |
| 2012 | 4 | 137 | 0 | 0 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 4 | 173 | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 2 | — | 0 | 0 |
| 2018 | 2 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 6 |
| 2020 | 0 | — | 0 | 7 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 1 | — | 0 | 6 |
| 2023 | 1 | — | 4 | 3 |
| 2024 | 2 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 13 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (147 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021801 · printed Nov 6, 2026
Cite this page
510(k) Report. “K021801: Bio-Logic Abaer Cub with Integrated Oae & Abr Functions.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K021801
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026