510(k) · Cleared
ClearedCadwell Sierra
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 Mar 23, 1993 after a 183-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 61 later devices descend from it.
- Decided
- Mar 23, 1993
- Review
- 183 days
- Class
- Class II
- Product code
- GWF
- Recalls
- None
- Predicates
- 0
61 later devices descend from it, 4 citing it directly.
- This deviceK924723 Cadwell SierraCadwell Laboratories, Inc. · 1993
- Descendant · cites it directly · 37 of its ownK962455 Four-Channel PreamplifierCadwell Laboratories, Inc. · 1997
- Descendant · 2 generations on · 35 of its ownK112718 Nuvasive NVM5 SystemNuvasive, Inc. · 2012
- Descendant · 3 generations on · 33 of its ownK123307 Nuvasive NVM5 SystemNuvasive, Inc. · 2013
- Descendant · cites it directly · 30 of its ownK112052 Carefusion Nicolet EdxCarefusion 209, Inc. · 2012
- Descendant · 4 generations on · 24 of its ownK132694 Nuvasive NVM5 SystemNu Vasive, Incorporated · 2014
Showing 5 of 61 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 61 · See all- K962455Four-Channel PreamplifierCadwell Laboratories, Inc. · 1997 · cites it directly37descendants
- K112718Nuvasive NVM5 SystemNuvasive, Inc. · 2012 · 2 generations on35descendants
- K123307Nuvasive NVM5 SystemNuvasive, Inc. · 2013 · 3 generations on33descendants
- K112052Carefusion Nicolet EdxCarefusion 209, Inc. · 2012 · cites it directly30descendants
- K132694Nuvasive NVM5 SystemNu Vasive, Incorporated · 2014 · 4 generations on24descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K924723 | Cadwell Sierra | Cadwell Laboratories, Inc. | 1993 | — |
| +1 | K962455 | Four-Channel Preamplifier | Cadwell Laboratories, Inc. | 1997 | — |
| +2 | K112718 | Nuvasive NVM5 System | Nuvasive, Inc. | 2012 | — |
| +3 | K123307 | Nuvasive NVM5 System | Nuvasive, Inc. | 2013 | — |
| +1 | K112052 | Carefusion Nicolet Edx | Carefusion 209, Inc. | 2012 | — |
| +4 | K132694 | Nuvasive NVM5 System | Nu Vasive, Incorporated | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 2 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 4 | 0 |
| 2013 | 2 | 0 |
| 2014 | 3 | 0 |
| 2015 | 3 | 0 |
| 2016 | 1 | 0 |
| 2017 | 7 | 0 |
| 2018 | 3 | 0 |
| 2019 | 5 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 4 | 0 |
| 2023 | 6 | 0 |
| 2024 | 5 | 0 |
| 2025 | 4 | 0 |
| 2026 | 7 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (61)
See all 614 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?
- Of its descendants, K962455 (Cadwell Laboratories, Inc., 1997) has gone furthest, with 37 descendants of its own.
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 | — |
https://510kreport.com/device/K924723 · printed Nov 6, 2026
Cite this page
510(k) Report. “K924723: Cadwell Sierra.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K924723
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026