510(k) · Cleared
Recalled · Class II · 2023Sentiero
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Path Medical GmbH · EWO Audiometer
Cleared on Jun 9, 2014 as substantially equivalent to K061744 (Bio-Logic Systems Corp., 2006) and 4 other predicates after a 257-day review. Its family tree reaches back 5 generations to 1990. 4 later devices descend from it. It has been recalled 4 times.
- Decided
- Jun 9, 2014
- Review
- 257 days
- Class
- Class II
- Product code
- EWO
- Recalls
- 4
- Predicates
- 5
Its longest line of descent runs back 5 generations to K902540 (1990). 25 ancestors in all. 4 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK902540 Gsi 17 Screening AudiometerGrason-Stadler, Inc. · 1990
- 4 generations backK974237 Gsi 70 Audiopath ScreenerGrason-Stadler, Inc. · 1998
- 3 generations backK982642 Echo-ScreenFischer-Zoth Audiologic Systems, Inc. · 1998
- 2 generations backK013977 Echo-Screen T, TA, TD, Tda, TCFischer-Zoth Audiologic Systems, Inc. · 2002
- 1 generation backK061744 Cochlea-Scan / Cochlea-Scan PlusBio-Logic Systems Corp. · 2006
- This deviceK133012 SentieroPath Medical GmbH · 2014
- Descendant · cites it directly · 1 of its ownK171038 Hearing Healthcare ProDb Diagnostic Systems, Inc. · 2017
- Descendant · cites it directly · 0 of its ownK220139 QScreenPath Medical GmbH · 2022
- Descendant · cites it directly · 0 of its ownK213345 Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, Sentiero…Path Medical GmbH · 2022 · Recalled
- Descendant · 2 generations on · 0 of its ownK183201 Hearing Healthcare ProDb Diagnostic Systems, Inc. · 2019
Most influential descendants
Showing 4 of 4 · See all- K171038Hearing Healthcare ProDb Diagnostic Systems, Inc. · 2017 · cites it directly1descendant
- K220139QScreenPath Medical GmbH · 2022 · cites it directly0descendants
- K213345Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, Sentiero Advanced, NavPRO ONEPath Medical GmbH · 2022 · cites it directly0descendants
- K183201Hearing Healthcare ProDb Diagnostic Systems, Inc. · 2019 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K902540 | Gsi 17 Screening Audiometer | Grason-Stadler, Inc. | 1990 | — |
| −4 | K974237 | Gsi 70 Audiopath Screener | Grason-Stadler, Inc. | 1998 | — |
| −3 | K982642 | Echo-Screen | Fischer-Zoth Audiologic Systems, Inc. | 1998 | — |
| −2 | K013977 | Echo-Screen T, TA, TD, Tda, TC | Fischer-Zoth Audiologic Systems, Inc. | 2002 | — |
| −1 | K061744 | Cochlea-Scan / Cochlea-Scan Plus | Bio-Logic Systems Corp. | 2006 | — |
| 0 (this device) | K133012 | Sentiero | Path Medical GmbH | 2014 | — |
| +1 | K171038 | Hearing Healthcare Pro | Db Diagnostic Systems, Inc. | 2017 | — |
| +1 | K220139 | QScreen | Path Medical GmbH | 2022 | — |
| +1 | K213345 | Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, Sentiero Advanced… | Path Medical GmbH | 2022 | 4 |
| +2 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 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? (5)
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 |
|---|---|---|---|
| * | K061744 | Cochlea-Scan / Cochlea-Scan PlusSummary page 1…ance Tester FDA 21 CFR section 882.1900 and 874.1050 and 874.1090 PREDICATE DEVICES Cochlea-Scan 510(k) number: K061744 AccuScreen 510(k) number: K122067 Chartr EP 200 510(k) number: K092373 TITAN IMP440… | 2006 |
| * | K122067 | Type 1077 AccuscreenSummary page 1…section 882.1900 and 874.1050 and 874.1090 PREDICATE DEVICES Cochlea-Scan 510(k) number: K061744 AccuScreen 510(k) number: K122067 Chartr EP 200 510(k) number: K092373 TITAN IMP440 510(k) number: K083861 Eclipse… | 2012 |
| * | K092373 | Ics Chartr EP 200Summary page 1…CES Cochlea-Scan 510(k) number: K061744 AccuScreen 510(k) number: K122067 Chartr EP 200 510(k) number: K092373 TITAN IMP440 510(k) number: K083861 Eclipse 510(k) number: K070696 DEVICE DES… | 2009 |
| * | K083861 | Titan, Titan Shoulder Box, Titan Cradle, Titan Printer, Titan IMP440, IMP440 Module…Summary page 1…744 AccuScreen 510(k) number: K122067 Chartr EP 200 510(k) number: K092373 TITAN IMP440 510(k) number: K083861 Eclipse 510(k) number: K070696 DEVICE DESCRIPTION Sentiero is an audiometric examination platform… | 2009 |
| * | K070696 | Interacoustics Assr, Eclipse System (Cabinet Name)Summary page 1…067 Chartr EP 200 510(k) number: K092373 TITAN IMP440 510(k) number: K083861 Eclipse 510(k) number: K070696 DEVICE DESCRIPTION Sentiero is an audiometric examination platform which consists of the Sentiero device with a touch screen… | 2007 |
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 26, 2023 | Class II | Z-0401-2024 | Process change control | Affected lots of product may experience technical distortions to a greater extent than expected. |
| Sep 26, 2023 | Class II | Z-0402-2024 | Process change control | Affected lots of product may experience technical distortions to a greater extent than expected. |
| Sep 26, 2023 | Class II | Z-0403-2024 | Process change control | Affected lots of product may experience technical distortions to a greater extent than expected. |
| Sep 26, 2023 | Class II | Z-0404-2024 | Process change control | Affected lots of product may experience technical distortions to a greater extent than expected. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 24 years and passes through 4 companies; a new generation was cleared every 4.3 years on median.
- 3 of the 25 ancestors have a recall of any class.
- Of its descendants, K171038 (Db Diagnostic Systems, Inc., 2017) has gone furthest, with 1 descendant of its own.
How does its category compare?
All EWO devicesEWO Audiometer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
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?
Sentiero is a portable instrument to diagnose all ages for hearing loss. The instrument offers different test methods which can be configured to fit the professional's needs for screening or diagnostic purposes. It offers physiological test methods such as: * Distortion Product Otoacoustic Emissions (DPOAE) * Transient Evoked Otoacoustic Emissions (TEOAE) * Auditory Brainstem Response (ABR) * Auditory Steady State Response (ASSR) * Auditory Impedance and…
Read the full statement (332 words)
Sentiero is a portable instrument to diagnose all ages for hearing loss. The instrument offers different test methods which can be configured to fit the professional's needs for screening or diagnostic purposes. It offers physiological test methods such as:
* Distortion Product Otoacoustic Emissions (DPOAE)
* Transient Evoked Otoacoustic Emissions (TEOAE)
* Auditory Brainstem Response (ABR)
* Auditory Steady State Response (ASSR)
* Auditory Impedance and acoustic reflex (TYMP) Additionally it offers standard audiometry (psycho-acoustical).
All physiological test methods are especially indicated for use in defining the type and configuration of hearing loss particularly for individuals whose behavioral audiometric results are deemed unreliable or to assist in the diagnosis of otologic disorders. Estimation of cochlear hearing thresholds (DPTHRESH) is possible at various frequencies without the need of cooperative interaction with the patient. Acoustic reflex and tympanometry (TYMP) are featured to evaluate the functional condition of the middle and outer ear. For each method, several protocols can be configured. The results are to be used to make further recommendations regarding appropriate intervention strategies. Therefore, Sentiero is intended for use by trained personnel such as audiologists, pediatricians, ENT doctors and other health care professionals. In the United States of America, Federal law restricts this device to sale by or on the order of a licensed physician.
Available psycho-acoustical methods on Sentiero are especially indicated for use with cooperative patients starting at the age of 2 years or adequate development age, which enables them to do play/interactive audiometry. All other modules are suitable to be used for all ages.
Sentiero is designed for:
1. Diagnostics, monitoring and follow-up after newborn hearing screening
2. Pre-school, school, and adult hearing screening
3. ENT diagnostics based on measurement of
* Otoacoustic emissions
* Tympanometry and acoustic reflex
* Auditory Brainstem Responses
* Auditory Steady State Responses
Sentiero must not be used in cases of external otitis (outer ear canal infection) or in any case which yields to pain when inserting the ear probe or applying any other transducer.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133012 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133012: Sentiero.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133012
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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