510(k) Report

510(k) · Cleared

Cleared

Handtymp

K923072510(k) TraditionalCleared Mar 18, 1993266-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

Life-Tech Intl., Inc. · ETY Tester, Auditory Impedance

Cleared on Mar 18, 1993 after a 266-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 4 later devices descend from it.

Decided
Mar 18, 1993
Review
266 days
Class
Class II
Product code
ETY
Recalls
None
Predicates
0

4 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2004: 1 descendant cleared2016: 1 descendant cleared2006: 1 descendant cleared2011: 1 descendant cleared1990200020102020
  1. This deviceK923072 HandtympLife-Tech Intl., Inc. · 1993
  2. Descendant · cites it directly · 3 of its ownK033645 Otoflex 100 Tye 1012Gn Otometrics A/S · 2004
  3. Descendant · 2 generations on · 1 of its ownK061104 Speechlink 100 Type 1053Gn Otometrics A/S · 2006
  4. Descendant · 2 generations on · 0 of its ownK161707 Madsen ZodiacGn Otometrics · 2016
  5. Descendant · 3 generations on · 0 of its ownK110286 GN Otometrics Type 1053 FreefitGn Otometrics A/S · 2011

Most influential descendants

Showing 4 of 4 · See all
  • K033645Otoflex 100 Tye 1012Gn Otometrics A/S · 2004 · cites it directly3descendants
  • K061104Speechlink 100 Type 1053Gn Otometrics A/S · 2006 · 2 generations on1descendant
  • K161707Madsen ZodiacGn Otometrics · 2016 · 2 generations on0descendants
  • K110286GN Otometrics Type 1053 FreefitGn Otometrics A/S · 2011 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K923072HandtympLife-Tech Intl., Inc.1993—
+1K033645Otoflex 100 Tye 1012Gn Otometrics A/S2004—
+2K061104Speechlink 100 Type 1053Gn Otometrics A/S2006—
+2K161707Madsen ZodiacGn Otometrics2016—
+3K110286GN Otometrics Type 1053 FreefitGn Otometrics A/S2011—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200610
201110
201610
FIG. 1 — Lineage of K923072, 1993–2016Source: 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), 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?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (4)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K033645Otoflex 100 Tye 1012Gn Otometrics A/S20043

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?

  • Of its descendants, K033645 (Gn Otometrics A/S, 2004) has gone furthest, with 3 descendants of its own.

How does its category compare?

All ETY devices

ETY Tester, Auditory Impedance: FDA decisions, review times, recalls and adverse event reports over 20 years.

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—

More from Life-Tech Intl., Inc.

68 FDA decisions under this applicant name. See the company

  • K001129Prolong, Models PL50, PL100, PL150Life-Tech Intl., Inc. · 20001 recall
  • K954505EZ StimLife-Tech Intl., Inc. · 1996
  • K955031MaxistimLife-Tech Intl., Inc. · 1996
  • K954315PVC Abdominal/Rectal Pressure CatheterLife-Tech Intl., Inc. · 1995
  • K954341Urodynamics Tubing and Infusion SetsLife-Tech Intl., Inc. · 1995

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/K923072 · printed Nov 4, 2026

Cite this page

510(k) Report. “K923072: Handtymp.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K923072

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026