510(k) · Cleared
ClearedArticulate Fitting System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Decibel Instruments, Inc. · EWO Audiometer
Cleared on Nov 25, 1997 as substantially equivalent to K940999 (Calmed Technology, Inc., 1994) and 1 other predicate after an 83-day review. Its family tree reaches back 1 generation to 1994.
- Decided
- Nov 25, 1997
- Review
- 83 days
- Class
- Class II
- Product code
- EWO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K940999 (1994). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK940999 Prodigit 2000Calmed Technology, Inc. · 1994
- This deviceK973320 Articulate Fitting SystemDecibel Instruments, Inc. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K940999 | Prodigit 2000 | Calmed Technology, Inc. | 1994 | — |
| 0 (this device) | K973320 | Articulate Fitting System | Decibel Instruments, Inc. | 1997 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 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 EWO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new EWO device
- #1 K234095 OtoNova/OtoNova Proscore 9.4 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K940999 | Prodigit 2000Summary page 1…21 CFR § 874.1050 Legally Marketed Predicate Devices: The legally marketed predicate devices are: e The Decibel Instruments ProDigit 2000™ Personal Digital Audiometer (K940999), determined to be substantially equivalent to a legally marketed (preAmendment) device on April 22, 1994, and e The Madsen Elec… | 1994 |
| * | K945199 | RH2000 Real Ear Measurement SystemSummary page 1…etermined to be substantially equivalent to a legally marketed (preAmendment) device on April 22, 1994, and e The Madsen Electronics RH2000 Real Ear Measurement System (K945199), determined to be substantially equivalent to a legally marketed (preAmendment) device on April 11, 1995. Device Description: T… | 1995 |
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?
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K940999.
How does its category compare?
All EWO devicesEWO Audiometer: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EWO
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · EWO
173in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EWO
4in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EWO
13in 2025
MAUDE reports naming product code EWO, 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 | 5 | 69 | 0 | 1 |
| 2008 | 1 | — | 1 | 1 |
| 2009 | 2 | — | 0 | 1 |
| 2010 | 2 | — | 0 | 4 |
| 2011 | 3 | 151 | 0 | 2 |
| 2012 | 4 | 137 | 0 | 0 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 4 | 173 | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 2 | — | 0 | 0 |
| 2018 | 2 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 6 |
| 2020 | 0 | — | 0 | 7 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 1 | — | 0 | 6 |
| 2023 | 1 | — | 4 | 3 |
| 2024 | 2 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 13 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Articulate Fitting System™ is used with the ProDigit 2000™ Personal Digital Audiometer to fit and program Articulate Hearing Devices. The ProDigit 2000™ Audiometer produces controlled levels of test tones and signals intended for use in conducting diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders.
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/K973320 · printed Nov 4, 2026
Cite this page
510(k) Report. “K973320: Articulate Fitting System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K973320
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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