510(k) · Cleared
ClearedHearing Healthcare Pro
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Db Diagnostic Systems, Inc. · ETY Tester, Auditory Impedance
Cleared on Mar 6, 2019 as substantially equivalent to K171038 (Db Diagnostic Systems, Inc., 2017) after a 107-day review. Its family tree reaches back 7 generations to 1990.
- Decided
- Mar 6, 2019
- Review
- 107 days
- Class
- Class II
- Product code
- ETY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K902540 (1990). 27 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK902540 Gsi 17 Screening AudiometerGrason-Stadler, Inc. · 1990
- 6 generations backK974237 Gsi 70 Audiopath ScreenerGrason-Stadler, Inc. · 1998
- 5 generations backK982642 Echo-ScreenFischer-Zoth Audiologic Systems, Inc. · 1998
- 4 generations backK013977 Echo-Screen T, TA, TD, Tda, TCFischer-Zoth Audiologic Systems, Inc. · 2002
- 3 generations backK061744 Cochlea-Scan / Cochlea-Scan PlusBio-Logic Systems Corp. · 2006
- 2 generations backK133012 SentieroPath Medical GmbH · 2014 · Recalled
- 1 generation backK171038 Hearing Healthcare ProDb Diagnostic Systems, Inc. · 2017
- This deviceK183201 Hearing Healthcare ProDb Diagnostic Systems, Inc. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K902540 | Gsi 17 Screening Audiometer | Grason-Stadler, Inc. | 1990 | — |
| −6 | K974237 | Gsi 70 Audiopath Screener | Grason-Stadler, Inc. | 1998 | — |
| −5 | K982642 | Echo-Screen | Fischer-Zoth Audiologic Systems, Inc. | 1998 | — |
| −4 | K013977 | Echo-Screen T, TA, TD, Tda, TC | Fischer-Zoth Audiologic Systems, Inc. | 2002 | — |
| −3 | K061744 | Cochlea-Scan / Cochlea-Scan Plus | Bio-Logic Systems Corp. | 2006 | — |
| −2 | K133012 | Sentiero | Path Medical GmbH | 2014 | 4 |
| −1 | K171038 | Hearing Healthcare Pro | Db Diagnostic Systems, Inc. | 2017 | — |
| 0 (this device) | K183201 | Hearing Healthcare Pro | Db Diagnostic Systems, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1997 | 2 | 0 |
| 1999 | 3 | 0 |
| 2000 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 3 | 0 |
| 2012 | 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 ETY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K171038 | Hearing Healthcare ProSummary page 4…874.1090 Product Code: ETY Classification Panel: Ear Nose & Throat Device Classification: II 3. PREDICATE DEVICE K171038 – Hearing Healthcare Pro manufactured by dB Diagnostic Systems, Inc. 4. DEVICE DESCRIPTION The Hearing Healthcare (HHC) Pr… | 2017 |
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 29 years and passes through 5 companies; a new generation was cleared every 3.6 years on median.
- 4 of the 27 ancestors have a recall of any class.
How does its category compare?
All ETY devicesETY Tester, Auditory Impedance: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · ETY
1in 2019
2026 to Oct 25, outlined.
Median 510(k) review, days · ETY
Too few ETY 510(k)s in any year since 2007 to give a median.
Recalls per year · ETY
No recall names ETY since 2007.
Adverse event reports per year · ETY
1in 2025
MAUDE reports naming product code ETY, 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 | 1 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 2 | — | 0 | 0 |
| 2016 | 2 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Hearing Healthcare Pro software will capture audiometry test results, and will allow user input of tympanometry results, physical examination results, and patient history. The software will summarize the inputted data and provide a “normal” or “abnormal” determination. If the decision is “abnormal”, the software can make a recommendation for clinical follow-up. The dB Diagnostic Systems, Inc. software is for adult use only and may be used by healthcare providers not normally trained or experienced in hearing, audiology, or otology, such as primary care providers.
The Hearing Healthcare Pro software is not intended to make a clinical diagnosis.
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/K183201 · printed Nov 3, 2026
Cite this page
510(k) Report. “K183201: Hearing Healthcare Pro.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K183201
Report an extraction error
Are you the manufacturer?
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