510(k) · Cleared
ClearedGN Otometrics Type 1053 Freefit
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 Apr 28, 2011 as substantially equivalent to K061104 (Gn Otometrics A/S, 2006) after an 87-day review. Its family tree reaches back 3 generations to 1989.
- Decided
- Apr 28, 2011
- Review
- 87 days
- Class
- Class II
- Product code
- ETW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K884046 (1989). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK884046 Audioscan (TM) Real Ear Measurement System RM500Etymonic Design, Inc. · 1989
- 2 generations backK012306 Audioscan Verifit, Model VF-1Etymonic Design, Inc. · 2001
- 1 generation backK061104 Speechlink 100 Type 1053Gn Otometrics A/S · 2006
- This deviceK110286 GN Otometrics Type 1053 FreefitGn Otometrics A/S · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K884046 | Audioscan (TM) Real Ear Measurement System RM500 | Etymonic Design, Inc. | 1989 | — |
| −2 | K012306 | Audioscan Verifit, Model VF-1 | Etymonic Design, Inc. | 2001 | — |
| −1 | K061104 | Speechlink 100 Type 1053 | Gn Otometrics A/S | 2006 | — |
| 0 (this device) | 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 |
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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K061104 | Speechlink 100 Type 1053Summary page 1…Predicate Device Product Name: SpeechLink 100 Type 1053 510(k) Number: K061 104 Classification Name: Calibrator, Hearing Aid/Earphone And… | 2006 |
What descends from it?
No later submission names this one as a predicate yet.
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 22 years and passes through 2 companies; a new generation was cleared every 5.0 years on median.
- None of the 7 ancestors has a recall.
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. 2011, this device’s year, is highlighted.
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?
Type 1053 FreeFit is intended for audiologists, hearing instrument dispensers, ENTs, speech therapists and other health care professionals. The intended use is that the user is able to visualize the amplified signal recorded in the ear(s) of persons with a hearing loss together with reference information such as target curves in order for the user to have an objective basis for adjusting the Hearing instrument settings.
Note also that the Type 1053 FreeFit is designed for use in combination with NOAHLink -HIMSA's wireless hearing instrument programming device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110286 · printed Nov 3, 2026
Cite this page
510(k) Report. “K110286: GN Otometrics Type 1053 Freefit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K110286
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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