510(k) · Cleared
ClearedSpeechlink 100 Type 1053
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gn Otometrics A/S · ETW Calibrator, Hearing Aid / Earphone And Analysis Systems
Cleared on May 3, 2006 as substantially equivalent to K012306 (Etymonic Design, Inc., 2001) and 1 other predicate after a 13-day review. Its family tree reaches back 2 generations to 1989. 1 later device descends from it.
- Decided
- May 3, 2006
- Review
- 13 days
- Class
- Class II
- Product code
- ETW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K884046 (1989). 6 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK884046 Audioscan (TM) Real Ear Measurement System RM500Etymonic Design, Inc. · 1989
- 1 generation backK012306 Audioscan Verifit, Model VF-1Etymonic Design, Inc. · 2001
- This deviceK061104 Speechlink 100 Type 1053Gn Otometrics A/S · 2006
- Descendant · cites it directly · 0 of its ownK110286 GN Otometrics Type 1053 FreefitGn Otometrics A/S · 2011
Most influential descendants
Showing 1 of 1 · See all- K110286GN Otometrics Type 1053 FreefitGn Otometrics A/S · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K884046 | Audioscan (TM) Real Ear Measurement System RM500 | Etymonic Design, Inc. | 1989 | — |
| −1 | K012306 | Audioscan Verifit, Model VF-1 | Etymonic Design, Inc. | 2001 | — |
| 0 (this device) | K061104 | Speechlink 100 Type 1053 | Gn Otometrics A/S | 2006 | — |
| +1 | K110286 | GN Otometrics Type 1053 Freefit | Gn Otometrics A/S | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 2000 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 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 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
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K012306 | Audioscan Verifit, Model VF-1 | 2001 |
| * | K033645 | Otoflex 100 Tye 1012Summary page 1…battery, number of tests available and wireless computer interface. Wireless computer interface and battery operation is currently performed by Otoflex 100 Type 10 12 (K033645). Description The SpeechLink is a PC-based system that contains hardware and software for one or more applications. The applicat… | 2004 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K110286 | GN Otometrics Type 1053 Freefit | 2011 | 0 |
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 17 years and passes through 2 companies; a new generation was cleared every 12.6 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K110286 (Gn Otometrics A/S, 2011) has gone furthest, with 0 descendants of its own.
How does its category compare?
All ETW devicesETW 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
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
MAUDE reports naming product code ETW, 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 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 2 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 5 |
| 2020 | 0 | — | 0 | 4 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The SpeechLink 100 is a hearing aid calibrator and analysis system that is an electronic reference device intended to calibrate and assess the electroacoustic frequency and sound intensity characteristics emanating from a hearing aid.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061104 · printed Nov 6, 2026
Cite this page
510(k) Report. “K061104: Speechlink 100 Type 1053.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061104
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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