510(k) · Cleared
ClearedFLASH EVD System (10-0002)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
7D Surgical ULC · HAW Neurological Stereotaxic Instrument
Cleared on Dec 27, 2024 as substantially equivalent to K192945 (7D Surgical, Inc., 2019) after a 128-day review. Its family tree reaches back 5 generations to 2000.
- Decided
- Dec 27, 2024
- Review
- 128 days
- Class
- Class II
- Product code
- HAW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K993239 (2000). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK993239 Stryker Navigation System - Neuro Module, Model 6000-XXX-XXXStryker Corp. · 2000 · Recalled
- 4 generations backK062640 Stryker Navigation System - Cranial Module, Model 6000-650-000Stryker Instruments · 2006 · Recalled
- 3 generations backK142024 Brightmatter Navigation SystemSynaptive Medical, Inc. · 2015 · Recalled
- 2 generations backK181041 7D Surgical System Cranial Application7D Surgical, Inc. · 2018
- 1 generation backK192945 7D Surgical System Cranial Biopsy and Ventricular Catheter Placement…7D Surgical, Inc. · 2019
- This deviceK242480 FLASH EVD System (10-0002)7D Surgical ULC · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K993239 | Stryker Navigation System - Neuro Module, Model 6000-XXX-XXX | Stryker Corp. | 2000 | 6 |
| −4 | K062640 | Stryker Navigation System - Cranial Module, Model 6000-650-000 | Stryker Instruments | 2006 | 19 |
| −3 | K142024 | Brightmatter Navigation System | Synaptive Medical, Inc. | 2015 | 1 |
| −2 | K181041 | 7D Surgical System Cranial Application | 7D Surgical, Inc. | 2018 | — |
| −1 | K192945 | 7D Surgical System Cranial Biopsy and Ventricular Catheter Placement Application | 7D Surgical, Inc. | 2019 | — |
| 0 (this device) | K242480 | FLASH EVD System (10-0002) | 7D Surgical ULC | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2005 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 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? (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 |
|---|---|---|---|
| * | K192945 | 7D Surgical System Cranial Biopsy and Ventricular Catheter Placement ApplicationSummary page 5…oduct 510(k) 7D Surgical System Cranial Biopsy and Ventricular Catheter Placement K192945 Application The intended use of the subject device, FLASH EVD System, is equivalent to the predicate device K192945 7D Surgica… | 2019 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 24 years and passes through 5 companies; a new generation was cleared every 5.1 years on median.
- 5 of the 9 ancestors have a recall of any class.
- 1 other device also cites its predicate K192945.
How does its category compare?
All HAW devicesHAW Neurological Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
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?
FLASH EVD is a stereotactic image guidance system intended for the spatial positioning and orientation of neurosurgical instruments. The device is only indicated for cranial surgery where reference to a rigid anatomical structure can be identified, does not require rigid fixation of the patient, and does not require fixation of a navigated instrument guide to the patient.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K242480 · printed Nov 6, 2026
Cite this page
510(k) Report. “K242480: FLASH EVD System (10-0002).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K242480
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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