510(k) · Cleared
ClearedSmart Coupler, Model M015401
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 Feb 28, 2008 as substantially equivalent to K031713 (Viasys Healthcare, Inc., 2003) after an 87-day review. Its family tree reaches back 3 generations to 1990.
- Decided
- Feb 28, 2008
- Review
- 87 days
- Class
- Class II
- Product code
- GWJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K902540 (1990). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK902540 Gsi 17 Screening AudiometerGrason-Stadler, Inc. · 1990
- 2 generations backK974237 Gsi 70 Audiopath ScreenerGrason-Stadler, Inc. · 1998
- 1 generation backK031713 Audiometer, Otoacoustic Emission, Auditory Branstem Response AccessViasys Healthcare, Inc. · 2003
- This deviceK073384 Smart Coupler, Model M015401Intelligent Hearing Systems · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K902540 | Gsi 17 Screening Audiometer | Grason-Stadler, Inc. | 1990 | — |
| −2 | K974237 | Gsi 70 Audiopath Screener | Grason-Stadler, Inc. | 1998 | — |
| −1 | K031713 | Audiometer, Otoacoustic Emission, Auditory Branstem Response Access | Viasys Healthcare, Inc. | 2003 | — |
| 0 (this device) | K073384 | Smart Coupler, Model M015401 | Intelligent Hearing Systems | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 2000 | 1 | 0 |
| 2003 | 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? (1)
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 |
|---|---|---|---|
| * | K031713 | Audiometer, Otoacoustic Emission, Auditory Branstem Response AccessSummary page 1…Coupler Proprietary Name: Smart Coupler Predicate Device: VIASYS Healthcare Comfort Cup & Ear Tip Accessories (K03 1713) Device Description: The Smart Coupler is a non-invasive, cutaneous, passive, sound- d… | 2003 |
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 18 years and passes through 3 companies; a new generation was cleared every 5.5 years on median.
- None of the 7 ancestors has a recall.
How does its category compare?
All GWJ devicesGWJ Stimulator, Auditory, Evoked Response: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
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 Smart Coupler is a passive, ear-coupling, sound-delivery device accessory intended for short-term, non-invasive use to support auditory evaluation studies (including use with audiometers, auditory evoked potential and otoacoustic emissions devices) on patients of all ages. The Smart Coupler is a biocompatible, non-sterile, single patient use, disposable device. The Smart Coupler is intended to be used by trained personnel in a hospital, nursery…
Read the full statement (132 words)
The Smart Coupler is a passive, ear-coupling, sound-delivery device accessory intended for short-term, non-invasive use to support auditory evaluation studies (including use with audiometers, auditory evoked potential and otoacoustic emissions devices) on patients of all ages. The Smart Coupler is a biocompatible, non-sterile, single patient use, disposable device.
The Smart Coupler is intended to be used by trained personnel in a hospital, nursery, clinic, audiologist's, or physician's office or other appropriate setting.
The anatomical sites of contact for the Smart Coupler are the external skin surrounding the ear (circumaural model), the external skin of the outer ear (supra-aural model), or the external skin of the ear canal (intra-aural model) with the contact object being a thin layer of medical-grade, biocompatible adhesive hydrogel, used for adhering the Smart Coupler device to the patient.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073384 · printed Nov 6, 2026
Cite this page
510(k) Report. “K073384: Smart Coupler, Model M015401.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K073384
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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