510(k) · Cleared
ClearedOpti-Amp DC-Powered
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Intelligent Hearing Systems · GWL Amplifier, Physiological Signal
Cleared on Aug 31, 2005 as substantially equivalent to K914876 (Intelligent Hearing Systems, 1992) after a 33-day review. Its family tree reaches back 1 generation to 1992. 2 later devices descend from it.
- Decided
- Aug 31, 2005
- Review
- 33 days
- Class
- Class II
- Product code
- GWL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K914876 (1992). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK914876 Opti-AmpIntelligent Hearing Systems · 1992
- This deviceK052060 Opti-Amp DC-PoweredIntelligent Hearing Systems · 2005
- Descendant · cites it directly · 1 of its ownK061443 Smart Usblite, Model M011120Intelligent Hearing Systems · 2006
- Descendant · 2 generations on · 0 of its ownK193033 GSI Audera ProGrason Stadler · 2020
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 | K914876 | Opti-Amp | Intelligent Hearing Systems | 1992 | — |
| 0 (this device) | K052060 | Opti-Amp DC-Powered | Intelligent Hearing Systems | 2005 | — |
| +1 | K061443 | Smart Usblite, Model M011120 | Intelligent Hearing Systems | 2006 | — |
| +2 | K193033 | GSI Audera Pro | Grason Stadler | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2020 | 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 GWL? 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 GWL device
- #1 K232210 X-trodes System Mscore 10.4 · 13 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 |
|---|---|---|---|
| * | K914876 | Opti-AmpSummary page 1…ked Potential Amplifier Classification Name: Physiological Signal Amplifier (per CER 882.1835) Predicate Device: Opti-Amp (K9 14876) Device Description: Opti-Amp DC-Powered is a bio-amplifier testing device (made… | 1992 |
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 |
|---|---|---|---|
| K061443 | Smart Usblite, Model M011120 | 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, K061443 (Intelligent Hearing Systems, 2006) has gone furthest, with 1 descendant of its own.
How does its category compare?
All GWL devicesGWL Amplifier, Physiological Signal: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GWL
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GWL
133in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GWL
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GWL
1in 2018
MAUDE reports naming product code GWL, 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 | 2 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 1 | — | 1 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 2 | — | 0 | 0 |
| 2013 | 0 | — | 1 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 2 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 2 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 4 | 133 | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The intended use of the Opti-Amp DC-Powered is as a physiological signal amplifier. It is intended to be used by trained personnel in a hospital, nursery, clinic, audiologist's office or other appropriate setting.
The anatomical site of contact is the patient's outer skin surface with electrodes placed to acquire a bio-electric surface signal.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052060 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052060: Opti-Amp DC-Powered.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052060
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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