510(k) · Cleared
ClearedCosgrove Depth Electrode Kit (Cdek)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Radionics, Inc. · HAW Neurological Stereotaxic Instrument
Cleared on Aug 7, 1996 as substantially equivalent to K944463 (Radionics Software Applications, Inc., 1995) and 1 other predicate after an 85-day review. Its family tree reaches back 1 generation to 1981. 18 later devices descend from it.
- Decided
- Aug 7, 1996
- Review
- 85 days
- Class
- Class II
- Product code
- HAW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K811452 (1981). 2 ancestors in all. 18 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK811452 Brown-Roberts-Wells Stereotaxic SytemTrent Wells, Inc. · 1981
- This deviceK961858 Cosgrove Depth Electrode Kit (Cdek)Radionics, Inc. · 1996
- Descendant · cites it directly · 17 of its ownK991522 Microtargeting ElectrodeFHC, Inc. · 2000 · Recalled
- Descendant · cites it directly · 16 of its ownK033173 Micro Targeting ElectrodeFHC, Inc. · 2004
- Descendant · 2 generations on · 12 of its ownK041604 Macro-Micro Depth ElectrodeAd-Tech Medical Instrument Corp · 2004
- Descendant · 3 generations on · 11 of its ownK053358 Depth Electrode, Foramen Ovale Depth Electrodes, Wyler Sphenoidal…Ad-Tech Medical Instrument Corp · 2006
- Descendant · 4 generations on · 5 of its ownK170959 DIXI Medical Microdeep Depth ElectrodeDixi Medical · 2017 · Recalled
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K991522Microtargeting ElectrodeFHC, Inc. · 2000 · cites it directly17descendants
- K033173Micro Targeting ElectrodeFHC, Inc. · 2004 · cites it directly16descendants
- K041604Macro-Micro Depth ElectrodeAd-Tech Medical Instrument Corp · 2004 · 2 generations on12descendants
- K053358Depth Electrode, Foramen Ovale Depth Electrodes, Wyler Sphenoidal Depth ElectrodesAd-Tech Medical Instrument Corp · 2006 · 3 generations on11descendants
- K170959DIXI Medical Microdeep Depth ElectrodeDixi Medical · 2017 · 4 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K811452 | Brown-Roberts-Wells Stereotaxic Sytem | Trent Wells, Inc. | 1981 | — |
| 0 (this device) | K961858 | Cosgrove Depth Electrode Kit (Cdek) | Radionics, Inc. | 1996 | — |
| +1 | K991522 | Microtargeting Electrode | FHC, Inc. | 2000 | 3 |
| +1 | K033173 | Micro Targeting Electrode | FHC, Inc. | 2004 | — |
| +2 | K041604 | Macro-Micro Depth Electrode | Ad-Tech Medical Instrument Corp | 2004 | — |
| +3 | K053358 | Depth Electrode, Foramen Ovale Depth Electrodes, Wyler Sphenoidal Depth… | Ad-Tech Medical Instrument Corp | 2006 | — |
| +4 | K170959 | DIXI Medical Microdeep Depth Electrode | Dixi Medical | 2017 | 9 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2004 | 3 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2017 | 3 | 0 |
| 2021 | 3 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 HAW? 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 HAW device
- #1 K253856 Geniant Cranial (Navigated Neurosurgical…score 15.0 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K944463 | CRW-1 SystemSummary page 1…ared through the FDA. Todd-Wells Stereotaxic Guide and Accessories, (pre- Predicate Device amendment); manufactured by Radionics Radionics CRW Stereotactic Arc System (K944463); Radionics BRW Stereotactic Arc System (K811452); Radionics Bipolar Forceps, (pre-amendment) Establishment Name and Address:… | 1995 |
| * | K811452 | Brown-Roberts-Wells Stereotaxic SytemSummary page 1…e and Accessories, (pre- Predicate Device amendment); manufactured by Radionics Radionics CRW Stereotactic Arc System (K944463); Radionics BRW Stereotactic Arc System (K811452); Radionics Bipolar Forceps, (pre-amendment) Establishment Name and Address: Radionics, Inc. 22 Terry Ave. Burlington, MA 01803… | 1981 |
| * | — | Todd-Wells Stereotaxic Guide and Accessories Named without a submission number | |
| * | — | Radionics Bipolar Forceps Named without a submission number |
What descends from it? (18)
See all 182 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 HAW devicesHAW Neurological Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HAW
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HAW
163in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HAW
2in 2025
Class I (9 since 2007) Class II/III not classified
Adverse event reports per year · HAW
3,425in 2025
MAUDE reports naming product code HAW, 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 | 15 | 107 | 2 | 49 |
| 2008 | 12 | 112 | 10 | 53 |
| 2009 | 8 | 221 | 6 | 96 |
| 2010 | 6 | 138 | 28 | 299 |
| 2011 | 4 | 66 | 5 | 1,725 |
| 2012 | 8 | 178 | 4 | 986 |
| 2013 | 3 | 172 | 6 (1) | 1,290 |
| 2014 | 5 | 238 | 5 | 1,606 |
| 2015 | 10 | 232 | 3 | 1,767 |
| 2016 | 9 | 175 | 5 | 1,828 |
| 2017 | 7 | 226 | 2 | 3,505 |
| 2018 | 6 | 112 | 2 (2) | 4,439 |
| 2019 | 10 | 147 | 4 (1) | 6,062 |
| 2020 | 5 | 88 | 1 | 3,480 |
| 2021 | 9 | 168 | 4 (2) | 2,827 |
| 2022 | 7 | 128 | 1 | 1,929 |
| 2023 | 14 | 142 | 4 (1) | 2,510 |
| 2024 | 7 | 107 | 2 (2) | 3,755 |
| 2025 | 9 | 163 | 2 | 3,425 |
| 2026 | 5 | 162 | 6 | — |
What is it indicated for?
The Cosgrove Depth Electrode Kit (CDEK) allows the user to place and secure epilepsy electrodes via a lateral orthogonal surgical approach or stereotactically using Radionics CRW and BRW Stereotactic Arc Systems which have been cleared through the FDA.
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/K961858 · printed Nov 4, 2026
Cite this page
510(k) Report. “K961858: Cosgrove Depth Electrode Kit (Cdek).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K961858
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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