510(k) Report

510(k) · Cleared

Cleared

Audioscan (TM) Real Ear Measurement System RM500

K884046510(k) TraditionalCleared Feb 13, 1989140-day reviewClass II21 CFR 874.3310

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

Etymonic Design, Inc. · ETW Calibrator, Hearing Aid / Earphone And Analysis Systems

Cleared on Feb 13, 1989 after a 140-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.

Decided
Feb 13, 1989
Review
140 days
Class
Class II
Product code
ETW
Recalls
None
Predicates
0

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

Descendants, by year cleared 2001: 1 descendant cleared2006: 1 descendant cleared2011: 1 descendant cleared1990200020102020
  1. This deviceK884046 Audioscan (TM) Real Ear Measurement System RM500Etymonic Design, Inc. · 1989
  2. Descendant · cites it directly · 2 of its ownK012306 Audioscan Verifit, Model VF-1Etymonic Design, Inc. · 2001
  3. Descendant · 2 generations on · 1 of its ownK061104 Speechlink 100 Type 1053Gn Otometrics A/S · 2006
  4. Descendant · 3 generations on · 0 of its ownK110286 GN Otometrics Type 1053 FreefitGn Otometrics A/S · 2011

Most influential descendants

Showing 3 of 3 · See all
  • K012306Audioscan Verifit, Model VF-1Etymonic Design, Inc. · 2001 · cites it directly2descendants
  • K061104Speechlink 100 Type 1053Gn Otometrics A/S · 2006 · 2 generations on1descendant
  • 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)K884046Audioscan (TM) Real Ear Measurement System RM500Etymonic Design, Inc.1989—
+1K012306Audioscan Verifit, Model VF-1Etymonic Design, Inc.2001—
+2K061104Speechlink 100 Type 1053Gn Otometrics A/S2006—
+3K110286GN Otometrics Type 1053 FreefitGn Otometrics A/S2011—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200110
200610
201110
FIG. 1 — Lineage of K884046, 1989–2011Source: 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 ETW? 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 has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (3)

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

NumberDeviceApplicantDecidedDescendants
K012306Audioscan Verifit, Model VF-1Etymonic Design, Inc.20012

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, K012306 (Etymonic Design, Inc., 2001) has gone furthest, with 2 descendants of its own.

How does its category compare?

All ETW devices

ETW Calibrator, Hearing Aid / Earphone And Analysis Systems: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · ETW

2in 2012

2007: 12009: 12011: 12012: 2
2007high 2 (2012) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · ETW

Too few ETW 510(k)s in any year since 2007 to give a median.

Recalls per year · ETW

No recall names ETW since 2007.

Adverse event reports per year · ETW

1in 2025

2019: 52020: 42021: 52022: 22024: 22025: 1
2007high 5 (2019) · low 0 (2007)2025

MAUDE reports naming product code ETW, 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
20080—00
20091—00
20100—00
20111—00
20122—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—05
20200—04
20210—05
20220—02
20230—00
20240—02
20250—01
20260—0—

More from Etymonic Design, Inc.

2 FDA decisions under this applicant name. See the company

  • K012306Audioscan Verifit, Model VF-1Etymonic Design, Inc. · 2001

Recent decisions in ETW

The ETW category page

  • K122028Aurical HitGn Otometrics · 2012
  • K113831Primus Hearing Instrument Test UnitAuditdata A/S · 2012
  • K110286GN Otometrics Type 1053 FreefitGn Otometrics A/S · 2011
  • K093006Fonix ,Model 8000Frye Electronics, Inc. · 2009
  • K071462Unity 2 Hia & Probe ( for Use with Unity 2)Siemens Hearing Instruments, Inc. · 2007

https://510kreport.com/device/K884046 · printed Nov 6, 2026

Cite this page

510(k) Report. “K884046: Audioscan (TM) Real Ear Measurement System RM500.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K884046

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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