510(k) Report

510(k) · Cleared

Cleared

Titan, Titan Shoulder Box, Titan Cradle, Titan Printer, Titan IMP440, IMP440 Module, Titan Suite

K083861510(k) TraditionalCleared Apr 9, 2009106-day reviewClass II21 CFR 874.1090

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

Interacoustics AS · ETY Tester, Auditory Impedance

Cleared on Apr 9, 2009 as substantially equivalent to K994254 (International Distributors of Electronics For Medi, 2000) after a 106-day review. Its family tree reaches back 1 generation to 2000. 6 later devices descend from it.

Decided
Apr 9, 2009
Review
106 days
Class
Class II
Product code
ETY
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K994254 (2000). 6 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2014: 1 descendant cleared2012: 1 descendant cleared2022: 2 descendants cleared2017: 1 descendant cleared2019: 1 descendant clearedK994254 · Interacoustics AT235 Impedance Audiometer · International Distributors of Electronics For Medi · 2000200020052010201520202025
Descendants, by generation 1 generation forward: 2 descendants2 generations forward: 3 descendants3 generations forward: 1 descendant K994254 · Interacoustics AT235 Impedance Audiometer · International Distributors of Electronics For Medi · 20000
  1. Root · 1 generation backK994254 Interacoustics AT235 Impedance AudiometerInternational Distributors of Electronics For Medi · 2000
  2. This deviceK083861 Titan, Titan Shoulder Box, Titan Cradle, Titan Printer, Titan…Interacoustics AS · 2009
  3. Descendant · cites it directly · 4 of its ownK133012 SentieroPath Medical GmbH · 2014 · Recalled
  4. Descendant · 2 generations on · 1 of its ownK171038 Hearing Healthcare ProDb Diagnostic Systems, Inc. · 2017
  5. Descendant · 2 generations on · 0 of its ownK220139 QScreenPath Medical GmbH · 2022
  6. Descendant · 2 generations on · 0 of its ownK213345 Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, Sentiero…Path Medical GmbH · 2022 · Recalled
  7. Descendant · 3 generations on · 0 of its ownK183201 Hearing Healthcare ProDb Diagnostic Systems, Inc. · 2019

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2012: 12014: 12017: 12019: 12022: 2
2012high 2 (2022) · low 0 (2013)2026

Most influential descendants

Showing 5 of 6 · See all
  • K133012SentieroPath Medical GmbH · 2014 · cites it directly4descendants
  • K171038Hearing Healthcare ProDb Diagnostic Systems, Inc. · 2017 · 2 generations on1descendant
  • K220139QScreenPath Medical GmbH · 2022 · 2 generations on0descendants
  • K213345Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, Sentiero Advanced, NavPRO ONEPath Medical GmbH · 2022 · 2 generations on0descendants
  • K183201Hearing Healthcare ProDb Diagnostic Systems, Inc. · 2019 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K994254Interacoustics AT235 Impedance AudiometerInternational Distributors of Electronics For Medi2000—
0 (this device)K083861Titan, Titan Shoulder Box, Titan Cradle, Titan Printer, Titan IMP440, IMP440…Interacoustics AS2009—
+1K133012SentieroPath Medical GmbH20144
+2K171038Hearing Healthcare ProDb Diagnostic Systems, Inc.2017—
+2K220139QScreenPath Medical GmbH2022—
+2K213345Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, Sentiero Advanced…Path Medical GmbH20224
+3K183201Hearing Healthcare ProDb Diagnostic Systems, Inc.2019—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201210
201410
201710
201910
202220
FIG. 1 — Lineage of K083861, 2000–2022Source: 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 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
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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.

TypeNumberDeviceApplicantDecidedRecalls
*K994254Interacoustics AT235 Impedance Audiometer
Summary page 2
…Predicate Device Manufacture 510(k) No. Date Cleared AT235 lnteracoustics K994254 14/03/2000 DEVICE DESCRIPTION Product name: Titan 1MP440 Titan IMP440 consists of a handheld unit named Titan,…
International Distributors of Electronics For Medi2000—

Also cleared against K994254: 3 other devices →

What descends from it? (6)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K133012SentieroPath Medical GmbH20144
K121847TITANInteracoustics A/S20120

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?

  • Its one ancestor has no recall.
  • Of its descendants, K133012 (Path Medical GmbH, 2014) has gone furthest, with 4 descendants of its own.
  • 3 other devices also cite its predicate K994254.

How does its category compare?

All ETY devices

ETY Tester, Auditory Impedance: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · ETY

1in 2019

2007: 12008: 12009: 12012: 12014: 12015: 22016: 22017: 12019: 1
2007high 2 (2015) · low 0 (2010)2026

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

2011: 12013: 12021: 12024: 12025: 1
2007high 1 (2011) · low 0 (2007)2025

MAUDE reports naming product code ETY, 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
20071—00
20081—00
20091—00
20100—00
20110—01
20121—00
20130—01
20141—00
20152—00
20162—00
20171—00
20180—00
20191—00
20200—00
20210—01
20220—00
20230—00
20240—01
20250—01
20260—0—

What is it indicated for?

The Titan Impedance System is an electroacoustic test instrument that produces

controlled levels of test tones and signals intended for use in conduction diagnostic

hearing evaluations and assisting in the diagnosis of possible otologic disorders. It

features tympanometry and acoustics reflex.

Indications for use as stated in the FDA summary.

Also cleared against K994254

3 other devices cite the same predicate.

  • K151616AT235Interacoustics A/S · 2015
  • K112733ER35 Ero-Scan Pro Hearing Test SystemEtymotic Research, Inc. · 2011
  • K070880ER35 Ero-Scan Pro Hearing Test SystemEtymotic Research, Inc. · 2007

More from Interacoustics AS

4 FDA decisions under this applicant name. See the company

  • K090406EP15 Software Module, EP25 Software ModuleInteracoustics AS · 2009
  • K052562Eclipse (Cabinet Name), TEOAE25, EP15, or the Combination of Systems.Interacoustics AS · 2005
  • K043219Affinity (Cabinet Name), AC440, HIT440, or the Combination of SystemsInteracoustics AS · 2005

Recent decisions in ETY

The ETY category page

  • K183201Hearing Healthcare ProDb Diagnostic Systems, Inc. · 2019
  • K171038Hearing Healthcare ProDb Diagnostic Systems, Inc. · 2017
  • K162210touchTympMaico Diagnostics GmbH · 2016
  • K161707Madsen ZodiacGn Otometrics · 2016
  • K151616AT235Interacoustics A/S · 2015

https://510kreport.com/device/K083861 · printed Nov 6, 2026

Cite this page

510(k) Report. “K083861: Titan, Titan Shoulder Box, Titan Cradle, Titan Printer, Titan IMP440, IMP440 Module, Titan Suite.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083861

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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