510(k) · Cleared
ClearedAmplaid MK22
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Amplifon S.P.A. · GWF Stimulator, Electrical, Evoked Response
Cleared on Feb 6, 1998 as substantially equivalent to K861014 (Amplaid USA, Inc., 1986) after a 179-day review. Its family tree reaches back 1 generation to 1986.
- Decided
- Feb 6, 1998
- Review
- 179 days
- Class
- Class II
- Product code
- GWF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K861014 (1986). No later device cites it as a predicate yet.
- Root · 1 generation backK861014 Amplaid MK15 (Evoked Potential System)Amplaid USA, Inc. · 1986
- This deviceK972959 Amplaid MK22Amplifon S.P.A. · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K861014 | Amplaid MK15 (Evoked Potential System) | Amplaid USA, Inc. | 1986 | — |
| 0 (this device) | K972959 | Amplaid MK22 | Amplifon S.P.A. | 1998 | — |
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 GWF? 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 GWF device
- #1 K263010 ISIS Headboxes, ISIS Neurostimulator, ISIS…score 17.5 · 19 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K861014 | Amplaid MK15 (Evoked Potential System)Summary page 1…4GWIJ(auditory stimulator). . Equivalent legally marketed devices This product is similar in design and function to the Amplaid USA, Inc. Evoked Potentials System MK15 (K861014) . Indications for Use (intended uses) Electronystagmography (for identification of middle ear conditions), Electroneurography (… | 1986 |
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?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K861014.
How does its category compare?
All GWF devicesGWF Stimulator, Electrical, Evoked Response: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GWF
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GWF
92in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GWF
2so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GWF
1,034in 2025
MAUDE reports naming product code GWF, 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 | 3 | 69 | 0 | 2 |
| 2008 | 2 | — | 0 | 1 |
| 2009 | 5 | 178 | 0 | 1 |
| 2010 | 3 | 269 | 0 | 4 |
| 2011 | 2 | — | 0 | 10 |
| 2012 | 4 | 230 | 1 | 44 |
| 2013 | 3 | 174 | 0 | 89 |
| 2014 | 1 | — | 0 | 25 |
| 2015 | 2 | — | 1 | 22 |
| 2016 | 1 | — | 0 | 20 |
| 2017 | 3 | 169 | 0 | 60 |
| 2018 | 0 | — | 0 | 58 |
| 2019 | 1 | — | 0 | 94 |
| 2020 | 1 | — | 0 | 65 |
| 2021 | 2 | — | 0 | 55 |
| 2022 | 2 | — | 0 | 45 |
| 2023 | 2 | — | 0 | 150 |
| 2024 | 4 | 92 | 0 | 854 |
| 2025 | 1 | — | 0 | 1,034 |
| 2026 | 3 | 125 | 2 | — |
What is it indicated for?
The Amplaid MK22 is a multi-channel system for electrodiagnosis capable of performing multisensory evoked potential tests including:
5. Electronystagmography
6. Visual evoked potentials,
7. Auditory evoked potentials, and
8. Electrical (somatosensory) evoked potentials.
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/K972959 · printed Nov 5, 2026
Cite this page
510(k) Report. “K972959: Amplaid MK22.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K972959
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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