510(k) · Cleared
ClearedSmart Usblite, Model M011120
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Intelligent Hearing Systems · GWJ Stimulator, Auditory, Evoked Response
Cleared on Jun 23, 2006 as substantially equivalent to K904926 (Intelligent Hearing Systems, 1991) and 5 other predicates after a 30-day review. Its family tree reaches back 5 generations to 1993. 1 later device descends from it.
- Decided
- Jun 23, 2006
- Review
- 30 days
- Class
- Class II
- Product code
- GWJ
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 5 generations to K930328 (1993). 13 ancestors in all, the oldest K890124 (1989). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK930328 Navigator & Traveler Evoked Postential ProductBio-Logic Systems Corp. · 1993
- 4 generations backK992807 Bio-Logic Evoked Potential for Abaer IBio-Logic Systems Corp. · 1999
- 3 generations backK994149 Modification to Bio-Logic Evoked Potential for Abaer/ Navigator Pro.Bio-Logic Systems Corp. · 1999
- 2 generations backK021895 Bio-Logic Master Evoked Response SystemBio-Logic Systems Corp. · 2002
- 1 generation backK031051 Smartep-Assr, Model M811007Intelligent Hearing Systems · 2004
- This deviceK061443 Smart Usblite, Model M011120Intelligent Hearing Systems · 2006
- Descendant · cites it directly · 0 of its ownK193033 GSI Audera ProGrason Stadler · 2020
Most influential descendants
Showing 1 of 1 · See all- K193033GSI Audera ProGrason Stadler · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K930328 | Navigator & Traveler Evoked Postential Product | Bio-Logic Systems Corp. | 1993 | — |
| −4 | K992807 | Bio-Logic Evoked Potential for Abaer I | Bio-Logic Systems Corp. | 1999 | — |
| −3 | K994149 | Modification to Bio-Logic Evoked Potential for Abaer/ Navigator Pro. | Bio-Logic Systems Corp. | 1999 | — |
| −2 | K021895 | Bio-Logic Master Evoked Response System | Bio-Logic Systems Corp. | 2002 | — |
| −1 | K031051 | Smartep-Assr, Model M811007 | Intelligent Hearing Systems | 2004 | — |
| 0 (this device) | K061443 | Smart Usblite, Model M011120 | Intelligent Hearing Systems | 2006 | — |
| +1 | K193033 | GSI Audera Pro | Grason Stadler | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1997 | 2 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 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 GWJ? 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 GWJ device
- #1 K242954 Integrity V500 (Integrity, Integrity with VEMP)score 10.0 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K904926 | Smart-EPSummary page 1…n Name: Auditory Evoked Response Stimulator (per CFR 882.1900) & Audiometer (per CFR 874.1050) Predicate Device(s): SmartEP (K904926), SmartScreener (K925648), SmartOAE (K964426), SmartTrOAE (K023859), SmartEP-ASSR… | 1991 |
| * | K925648 | Smart-Screener (Auditory)Summary page 1…Evoked Response Stimulator (per CFR 882.1900) & Audiometer (per CFR 874.1050) Predicate Device(s): SmartEP (K904926), SmartScreener (K925648), SmartOAE (K964426), SmartTrOAE (K023859), SmartEP-ASSR (K031051), and… | 1993 |
| * | K964426 | SmartoaeSummary page 1…& Audiometer (per CFR 874.1050) Predicate Device(s): SmartEP (K904926), SmartScreener (K925648), SmartOAE (K964426), SmartTrOAE (K023859), SmartEP-ASSR (K031051), and Opti-Amp DC-Powered (K052060). Device Descriptio… | 1997 |
| * | K023859 | SmarttroaeSummary page 1…& Audiometer (per CFR 874.1050) Predicate Device(s): SmartEP (K904926), SmartScreener (K925648), SmartOAE (K964426), SmartTrOAE (K023859), SmartEP-ASSR (K031051), and Opti-Amp DC-Powered (K052060). Device Description: Smart USBL… | 2003 |
| * | K031051 | Smartep-Assr, Model M811007Summary page 1…s): SmartEP (K904926), SmartScreener (K925648), SmartOAE (K964426), SmartTrOAE (K023859), SmartEP-ASSR (K031051), and Opti-Amp DC-Powered (K052060). Device Description: Smart USBLite is an auditory evoked potential and… | 2004 |
| * | K052060 | Opti-Amp DC-PoweredSummary page 1…tScreener (K925648), SmartOAE (K964426), SmartTrOAE (K023859), SmartEP-ASSR (K031051), and Opti-Amp DC-Powered (K052060). Device Description: Smart USBLite is an auditory evoked potential and otoacoustic emissio… | 2005 |
| † | K914876 | Opti-Amp | 1992 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K193033 | GSI Audera Pro | 2020 | 0 |
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 13 years and passes through 2 companies; a new generation was cleared every 2.3 years on median.
- None of the 13 ancestors has a recall.
- Of its descendants, K193033 (Grason Stadler, 2020) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K904926.
How does its category compare?
All GWJ devicesGWJ Stimulator, Auditory, Evoked Response: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GWJ
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · GWJ
111in 2009
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GWJ
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GWJ
1in 2025
MAUDE reports naming product code GWJ, 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 | 2 | — | 0 | 0 |
| 2008 | 4 | 64 | 1 | 0 |
| 2009 | 4 | 111 | 0 | 0 |
| 2010 | 1 | — | 1 | 2 |
| 2011 | 2 | — | 0 | 5 |
| 2012 | 1 | — | 0 | 1 |
| 2013 | 2 | — | 0 | 1 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 3 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 2 | — | 0 | 43 |
| 2018 | 0 | — | 0 | 24 |
| 2019 | 0 | — | 1 | 5 |
| 2020 | 1 | — | 0 | 3 |
| 2021 | 1 | — | 0 | 3 |
| 2022 | 1 | — | 0 | 8 |
| 2023 | 0 | — | 0 | 6 |
| 2024 | 2 | — | 0 | 7 |
| 2025 | 0 | — | 1 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The intended use of the Smart USBLifte device system is for the recording of auditory evoked potential, otoacoustic emissions, & auditory steady-state evoked potential data. The product is intended to be used as a diagnostic aid in auditory and hearing related disorders, as an objective measure of cochlear function, and as an adjunctive tool in the estimation of behavioral hearing thresholds on patients of all ages. The Smart USBLite system combines the…
Read the full statement (168 words)
The intended use of the Smart USBLifte device system is for the recording of auditory evoked potential, otoacoustic emissions, & auditory steady-state evoked potential data. The product is intended to be used as a diagnostic aid in auditory and hearing related disorders, as an objective measure of cochlear function, and as an adjunctive tool in the estimation of behavioral hearing thresholds on patients of all ages.
The Smart USBLite system combines the following FDA 510(k) previously cleared devices into a repackaged, smaller-sized, single, integrated unit: SmartEP (K904926), SmartScreener (K925648), SmartOAE (K964426), SmartTrOAE (K023859), SmartEP-ASSR (K031051), and Opti-Amp DC-Powered (K052060).
The Smart USBLite is intended to be used by trained personnel in a hospital, nursery, clinic, audiologist’s office or other appropriate setting.
The anatomical sites of contact are:
(1) The patient’s scalp and possibly other body sites with the contact objects being electrodes that are capable of measuring bio-potentials
(2) The patient’s ear with the contact object being a sound delivery device eartip, headphone, ear probe, or ear cups.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K061443 · printed Nov 6, 2026
Cite this page
510(k) Report. “K061443: Smart Usblite, Model M011120.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061443
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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