510(k) · Cleared
ClearedAudioscan Verifit, Model VF-1
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Etymonic Design, Inc. · ETW Calibrator, Hearing Aid / Earphone And Analysis Systems
Cleared on Sep 21, 2001 as substantially equivalent to K884046 (Etymonic Design, Inc., 1989) after a 60-day review. Its family tree reaches back 1 generation to 1989. 2 later devices descend from it.
- Decided
- Sep 21, 2001
- Review
- 60 days
- Class
- Class II
- Product code
- ETW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K884046 (1989). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK884046 Audioscan (TM) Real Ear Measurement System RM500Etymonic Design, Inc. · 1989
- This deviceK012306 Audioscan Verifit, Model VF-1Etymonic Design, Inc. · 2001
- Descendant · cites it directly · 1 of its ownK061104 Speechlink 100 Type 1053Gn Otometrics A/S · 2006
- Descendant · 2 generations on · 0 of its ownK110286 GN Otometrics Type 1053 FreefitGn Otometrics A/S · 2011
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K884046 | Audioscan (TM) Real Ear Measurement System RM500 | Etymonic Design, Inc. | 1989 | — |
| 0 (this device) | K012306 | Audioscan Verifit, Model VF-1 | Etymonic Design, Inc. | 2001 | — |
| +1 | K061104 | Speechlink 100 Type 1053 | Gn Otometrics A/S | 2006 | — |
| +2 | K110286 | GN Otometrics Type 1053 Freefit | Gn Otometrics A/S | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K884046 | Audioscan (TM) Real Ear Measurement System RM500Summary page 2…: Determination of substantial equivalence of the Audioscan® Verifit™ VF-] instrument to the currently marketed Audioscan® Real Ear Measurement System RMS00, S10(k) No, K884046/A, Februery 13, 1989, is based on the following safety and effectiveness information: e The Audioscan® Verifit™ device is manufa… | 1989 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K061104 | Speechlink 100 Type 1053 | 2006 | 1 |
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, K061104 (Gn Otometrics A/S, 2006) has gone furthest, with 1 descendant 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 Audioscan® Verifit™ is a hearing aid analysis system that is an electronic reference device used by manufacturers and dispensers of hearing aids intended to calibrate and assess the electroacoustic frequency and sound intensity characteristics emanating from a hearing aid coupled to an ear simulator in a test chamber of a hearing aid when worn by a patient.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K012306 · printed Nov 6, 2026
Cite this page
510(k) Report. “K012306: Audioscan Verifit, Model VF-1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012306
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026