510(k) · Cleared
ClearedDS7A Constant Current High Voltage Stimulator, Model DS7A; DS7AH Constant Current High Voltage Stimulator, Model DS7AH
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Digitimer, Ltd. · GWF Stimulator, Electrical, Evoked Response
Cleared on Sep 20, 2005 as substantially equivalent to K020400 (Meps, LLC, 2002) after a 119-day review. Its family tree reaches back 1 generation to 2002. 40 later devices descend from it.
- Decided
- Sep 20, 2005
- Review
- 119 days
- Class
- Class II
- Product code
- GWF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K020400 (2002). 40 later devices descend from it, 5 citing it directly.
- Root · 1 generation backK020400 Digitimer D185 Multipulse Cortical StimulatorMeps, LLC · 2002
- This deviceK051357 DS7A Constant Current High Voltage Stimulator, Model DS7A; DS7AH…Digitimer, Ltd. · 2005
- 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 40 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 40 · 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 | K020400 | Digitimer D185 Multipulse Cortical Stimulator | Meps, LLC | 2002 | — |
| 0 (this device) | K051357 | DS7A Constant Current High Voltage Stimulator, Model DS7A; DS7AH Constant… | Digitimer, Ltd. | 2005 | — |
| +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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 5 | 0 |
| 2018 | 3 | 0 |
| 2019 | 4 | 0 |
| 2021 | 3 | 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? (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 |
|---|---|---|---|
| * | K020400 | Digitimer D185 Multipulse Cortical StimulatorSummary page 1…CFR § 882.1870 Device class: 2 Product code: OWE Predicate device 5 10(k) Number: K020400 Device Name: Digitimer DISS5 Multipulse Cortical Stimulator Common name: Evoked Potential S… | 2002 |
What descends from it? (40)
See all 405 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 DS7A and DS7AH are stinmilators intended for use during neurological monitoring and assessment in a clinical environment.
They are intended for use by trained personnel either competent to apply appropriate stimuli or under the supervision and instruction of one who is.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051357 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051357: DS7A Constant Current High Voltage Stimulator, Model DS7A; DS7AH Constant Current High Voltage Stimulator, Model DS7AH.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051357
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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