510(k) · Cleared
ClearedSurgivision MR Compatible Ventricular Cannula
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Surgivision, Inc. · HCD Cannula, Ventricular
Cleared on Jan 26, 2011 after a 183-day review. The FDA summary names its predicate without a number. 3 later devices descend from it.
- Decided
- Jan 26, 2011
- Review
- 183 days
- Class
- Class I
- Product code
- HCD
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 3 citing it directly.
- This deviceK102101 Surgivision MR Compatible Ventricular CannulaSurgivision, Inc. · 2011
- Descendant · cites it directly · 1 of its ownK150660 Alcyone MEMS Cannula (AMC) SystemAlcyone Lifesciences, Inc. · 2015
- Descendant · cites it directly · 1 of its ownK123605 Smartflow CatheterMri Interventions, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK161731 Cleveland Multiport Ventricular Catheter SetParker Hannifin Corp. · 2017
Most influential descendants
Showing 3 of 3 · See all- K150660Alcyone MEMS Cannula (AMC) SystemAlcyone Lifesciences, Inc. · 2015 · cites it directly1descendant
- K123605Smartflow CatheterMri Interventions, Inc. · 2013 · cites it directly1descendant
- K161731Cleveland Multiport Ventricular Catheter SetParker Hannifin Corp. · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K102101 | Surgivision MR Compatible Ventricular Cannula | Surgivision, Inc. | 2011 | — |
| +1 | K150660 | Alcyone MEMS Cannula (AMC) System | Alcyone Lifesciences, Inc. | 2015 | — |
| +1 | K123605 | Smartflow Catheter | Mri Interventions, Inc. | 2013 | — |
| +1 | K161731 | Cleveland Multiport Ventricular Catheter Set | Parker Hannifin Corp. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 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 HCD? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | — | Adson Cannula Named without a submission number |
What descends from it? (3)
3 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, K150660 (Alcyone Lifesciences, Inc., 2015) has gone furthest, with 1 descendant of its own.
How does its category compare?
All HCD devicesHCD Cannula, Ventricular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · HCD
1in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · HCD
Too few HCD 510(k)s in any year since 2007 to give a median.
Recalls per year · HCD
No recall names HCD since 2007.
Adverse event reports per year · HCD
10in 2019
MAUDE reports naming product code HCD, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 6 |
| 2019 | 0 | — | 0 | 10 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The MR Compatible Ventricular Cannula is intended for injection of Cytarabine or removal of CSF from the ventricles during intracranial procedures. The device is not intended for implant. The device is intended for "single patient use only."
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102101 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102101: Surgivision MR Compatible Ventricular Cannula.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102101
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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