510(k) · Cleared
ClearedFour-Channel Preamplifier
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cadwell Laboratories, Inc. · GWF Stimulator, Electrical, Evoked Response
Cleared on Jan 13, 1997 as substantially equivalent to K924723 (Cadwell Laboratories, Inc., 1993) and 1 other predicate after a 202-day review. Its family tree reaches back 1 generation to 1993. 37 later devices descend from it.
- Decided
- Jan 13, 1997
- Review
- 202 days
- Class
- Class II
- Product code
- GWF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K924723 (1993). 2 ancestors in all. 37 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK924723 Cadwell SierraCadwell Laboratories, Inc. · 1993
- This deviceK962455 Four-Channel PreamplifierCadwell Laboratories, Inc. · 1997
- Descendant · cites it directly · 35 of its ownK112718 Nuvasive NVM5 SystemNuvasive, Inc. · 2012
- Descendant · 2 generations on · 33 of its ownK123307 Nuvasive NVM5 SystemNuvasive, Inc. · 2013
- Descendant · 3 generations on · 24 of its ownK132694 Nuvasive NVM5 SystemNu Vasive, Incorporated · 2014
- Descendant · 4 generations on · 23 of its ownK141968 Nuvasive NVM5 SystemNuvasive, Inc. · 2014
- Descendant · 5 generations on · 22 of its ownK143641 NuVasive NVM5 SystemNu Vasive, Incorporated · 2015 · Recalled
Showing 5 of 37 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 37 · See all- K112718Nuvasive NVM5 SystemNuvasive, Inc. · 2012 · cites it directly35descendants
- K123307Nuvasive NVM5 SystemNuvasive, Inc. · 2013 · 2 generations on33descendants
- K132694Nuvasive NVM5 SystemNu Vasive, Incorporated · 2014 · 3 generations on24descendants
- K141968Nuvasive NVM5 SystemNuvasive, Inc. · 2014 · 4 generations on23descendants
- K143641NuVasive NVM5 SystemNu Vasive, Incorporated · 2015 · 5 generations on22descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K924723 | Cadwell Sierra | Cadwell Laboratories, Inc. | 1993 | — |
| 0 (this device) | K962455 | Four-Channel Preamplifier | Cadwell Laboratories, Inc. | 1997 | — |
| +1 | K112718 | Nuvasive NVM5 System | Nuvasive, Inc. | 2012 | — |
| +2 | K123307 | Nuvasive NVM5 System | Nuvasive, Inc. | 2013 | — |
| +3 | K132694 | Nuvasive NVM5 System | Nu Vasive, Incorporated | 2014 | — |
| +4 | K141968 | Nuvasive NVM5 System | Nuvasive, Inc. | 2014 | — |
| +5 | K143641 | NuVasive NVM5 System | Nu Vasive, Incorporated | 2015 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 4 | 0 |
| 2018 | 3 | 0 |
| 2019 | 4 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 4 | 0 |
| 2024 | 2 | 0 |
| 2025 | 3 | 0 |
| 2026 | 3 | 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 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? (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 |
|---|---|---|---|
| * | K924723 | Cadwell SierraSummary page 1…sting. The intent of this design is to reduce signal noise during procedures requiring high-impedance electrodes. The proposed device is for use with the Cadwell Sierra (K924723) and 6200A (K931428) EMG instruments. ' All device components are reusable and supplied non-sterile. The extension cable with el… | 1993 |
| * | K931428 | Cadwell 6200 aSummary page 1…this design is to reduce signal noise during procedures requiring high-impedance electrodes. The proposed device is for use with the Cadwell Sierra (K924723) and 6200A (K931428) EMG instruments. ' All device components are reusable and supplied non-sterile. The extension cable with electrode input box is… | 1993 |
What descends from it? (37)
See all 372 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
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 general purpose of the proposed device is identical to the predicate device: "to perform the measurements needed for electromyography (EMG), nerve conduction velocity (NCV, F wave, and H reflex), and evoked potentials (brainstem, visual, and somatosensory), and repetitive nerve stimulation." The purpose of the proposed device is to allow compatibility with high-impedance electrodes. The proposed device allows electrode inputs to be made closer to the source of the signal for reduced signal noise during procedures requiring high-impedance electrodes.
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/K962455 · printed Nov 6, 2026
Cite this page
510(k) Report. “K962455: Four-Channel Preamplifier.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K962455
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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