510(k) Report

510(k) · Cleared

Cleared

Neuro-Audio

K141524510(k) TraditionalCleared Mar 12, 2015276-day reviewClass II21 CFR 874.1050

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Teleemg, LLC USA · EWO Audiometer

Cleared on Mar 12, 2015 as substantially equivalent to K052562 (Interacoustics AS, 2005) and 5 other predicates after a 276-day review. Its family tree reaches back 5 generations to 1993.

Decided
Mar 12, 2015
Review
276 days
Class
Class II
Product code
EWO
Recalls
None
Predicates
6

Its longest line of descent runs back 5 generations to K930328 (1993). 10 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2006: 1 other ancestor2005: 2 other ancestors2003: 1 other ancestor2001: 1 other ancestorK930328 · Navigator & Traveler Evoked Postential Product · Bio-Logic Systems Corp. · 1993K992807 · Bio-Logic Evoked Potential for Abaer I · Bio-Logic Systems Corp. · 1999K994149 · Modification to Bio-Logic Evoked Potential for Abaer/ Navigator Pro. · Bio-Logic Systems Corp. · 1999K021895 · Bio-Logic Master Evoked Response System · Bio-Logic Systems Corp. · 2002K070696 · Interacoustics Assr, Eclipse System (Cabinet Name) · Interacoustics A/S · 2007199019952000200520102015
Other ancestors, by generation 1 generation back: 5 other ancestors K070696 · Interacoustics Assr, Eclipse System (Cabinet Name) · Interacoustics A/S · 2007K021895 · Bio-Logic Master Evoked Response System · Bio-Logic Systems Corp. · 2002K994149 · Modification to Bio-Logic Evoked Potential for Abaer/ Navigator Pro. · Bio-Logic Systems Corp. · 1999K992807 · Bio-Logic Evoked Potential for Abaer I · Bio-Logic Systems Corp. · 1999K930328 · Navigator & Traveler Evoked Postential Product · Bio-Logic Systems Corp. · 1993−50
  1. Root · 5 generations backK930328 Navigator & Traveler Evoked Postential ProductBio-Logic Systems Corp. · 1993
  2. 4 generations backK992807 Bio-Logic Evoked Potential for Abaer IBio-Logic Systems Corp. · 1999
  3. 3 generations backK994149 Modification to Bio-Logic Evoked Potential for Abaer/ Navigator Pro.Bio-Logic Systems Corp. · 1999
  4. 2 generations backK021895 Bio-Logic Master Evoked Response SystemBio-Logic Systems Corp. · 2002
  5. 1 generation backK070696 Interacoustics Assr, Eclipse System (Cabinet Name)Interacoustics A/S · 2007
  6. This deviceK141524 Neuro-AudioTeleemg, LLC USA · 2015
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K930328Navigator & Traveler Evoked Postential ProductBio-Logic Systems Corp.1993—
−4K992807Bio-Logic Evoked Potential for Abaer IBio-Logic Systems Corp.1999—
−3K994149Modification to Bio-Logic Evoked Potential for Abaer/ Navigator Pro.Bio-Logic Systems Corp.1999—
−2K021895Bio-Logic Master Evoked Response SystemBio-Logic Systems Corp.2002—
−1K070696Interacoustics Assr, Eclipse System (Cabinet Name)Interacoustics A/S2007—
0 (this device)K141524Neuro-AudioTeleemg, LLC USA2015—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200110
200310
200520
200610
FIG. 1 — Lineage of K141524, 1993–2015Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K234095 OtoNova/OtoNova Proscore 9.3 · 7 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against? (6)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K052562Eclipse (Cabinet Name), TEOAE25, EP15, or the Combination of Systems.
Summary page 4
…onse Regulation Number: 21 CFR §874.1050; 21 CFR §882.1900 Device Class: Class II Product Code: EWO; GWJ 3. PREDICATE DEVICES • Interacoustics EP25, Eclipse System, K052562 • Interacoustics TEOAE25, Eclipse System, K030016 • Interacoustics DPOAE2O, Eclipse System, K060539 • Interacoustics…
Interacoustics AS2005—
*K030016TEOAE25
Summary page 4
…1900 Device Class: Class II Product Code: EWO; GWJ 3. PREDICATE DEVICES • Interacoustics EP25, Eclipse System, K052562 • Interacoustics TEOAE25, Eclipse System, K030016 • Interacoustics DPOAE2O, Eclipse System, K060539 • Interacoustics ASSR, Eclipse System, K070696 • Interacoustics Aff…
Interacoustics A/S, Assens2003—
*K060539DPOAE20 , Eclipse
Summary page 4
…PREDICATE DEVICES • Interacoustics EP25, Eclipse System, K052562 • Interacoustics TEOAE25, Eclipse System, K030016 • Interacoustics DPOAE2O, Eclipse System, K060539 • Interacoustics ASSR, Eclipse System, K070696 • Interacoustics Affinity (AC440), K043219 • GSI Audera, K011135 4. D…
Interacoustics A/S, Assens2006—
*K070696Interacoustics Assr, Eclipse System (Cabinet Name)
Summary page 4
…se System, K052562 • Interacoustics TEOAE25, Eclipse System, K030016 • Interacoustics DPOAE2O, Eclipse System, K060539 • Interacoustics ASSR, Eclipse System, K070696 • Interacoustics Affinity (AC440), K043219 • GSI Audera, K011135 4. DEVICE DESCRIPTION The Neuro-Audio system provides f…
Interacoustics A/S2007—
*K043219Affinity (Cabinet Name), AC440, HIT440, or the Combination of Systems
Summary page 4
…, Eclipse System, K030016 • Interacoustics DPOAE2O, Eclipse System, K060539 • Interacoustics ASSR, Eclipse System, K070696 • Interacoustics Affinity (AC440), K043219 • GSI Audera, K011135 4. DEVICE DESCRIPTION The Neuro-Audio system provides for audiology biopotentials recording and input…
Interacoustics AS2005—
*K011135Gsi Audera
Summary page 4
…• Interacoustics DPOAE2O, Eclipse System, K060539 • Interacoustics ASSR, Eclipse System, K070696 • Interacoustics Affinity (AC440), K043219 • GSI Audera, K011135 4. DEVICE DESCRIPTION The Neuro-Audio system provides for audiology biopotentials recording and input to personal computer (PC)…
Nicolet Biomedical20011

Also cleared against K052562: 2 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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 22 years and passes through 3 companies; a new generation was cleared every 5.0 years on median.
  • 1 of the 10 ancestors has a recall of any class.
  • 2 other devices also cite its predicate K052562.

How does its category compare?

All EWO devices

EWO Audiometer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.

FDA decisions per year · EWO

2in 2024

2007: 52008: 12009: 22010: 22011: 32012: 42013: 22014: 12015: 42017: 22018: 22019: 12022: 12023: 12024: 2
2007high 5 (2007) · low 0 (2016)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · EWO

173in 2015

2007: 69 days median2011: 151 days median2012: 137 days median2015: 173 days median
2007high 173 (2015) · low 69 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · EWO

4in 2023

2008: 12023: 4
2007high 4 (2023) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · EWO

13in 2025

2007: 12008: 12009: 12010: 42011: 22015: 12019: 62020: 72021: 32022: 62023: 32024: 22025: 13
2007high 13 (2025) · low 0 (2012)2025

MAUDE reports naming product code EWO, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200756901
20081—11
20092—01
20102—04
2011315102
2012413700
20132—00
20141—00
2015417301
20160—00
20172—00
20182—00
20191—06
20200—07
20210—03
20221—06
20231—43
20242—02
20250—013
20260—0—

What is it indicated for?

The Neuro-Audio system is indicated for use in the recording and analysis of human physiological data used for the diagnosis of auditory and hearing-related functions. It is intended as an aid to healthcare professionals trained and skilled in audiology. The system assists in the evaluation, documentation and diagnosis of ear disorders in humans using evoked potentials (EP), electrocochleography (ECochG), auditory brainstem response (ABR), auditory…

Read the full statement (101 words)

The Neuro-Audio system is indicated for use in the recording and analysis of human physiological data used for the diagnosis of auditory and hearing-related functions. It is intended as an aid to healthcare professionals trained and skilled in audiology. The system assists in the evaluation, documentation and diagnosis of ear disorders in humans using evoked potentials (EP), electrocochleography (ECochG), auditory brainstem response (ABR), auditory steady-state response (ASSR), otoacoustic emission (OAE) and pure tone audiometry (PTA).

The device is intended for use in the patient care institutions, diagnostics centers, neurosurgical hospitals and experimental laboratories.

The patient group includes all ages and genders.

Indications for use as stated in the FDA summary.

Also cleared against K052562

2 other devices cite the same predicate.

  • K130795TITANInteracoustics A/S · 2013
  • K090406EP15 Software Module, EP25 Software ModuleInteracoustics AS · 2009

More from Teleemg, LLC USA

2 FDA decisions under this applicant name. See the company

  • K102610Focus Emg DeviceTeleemg, LLC USA · 2011

Recent decisions in EWO

The EWO category page

  • K234095OtoNova/OtoNova ProOtodynamics · 2024
  • K240430Otoport ProOtodynamics, Ltd. · 2024
  • K231545hearOAEHearx SA (Pty), Ltd. · 2023
  • K213345Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, Sentiero Advanced, NavPRO ONEPath Medical GmbH · 20224 recalls
  • K191372LyraInteracoustics A/S · 2019

https://510kreport.com/device/K141524 · printed Nov 6, 2026

Cite this page

510(k) Report. “K141524: Neuro-Audio.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141524

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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