510(k) · Cleared
ClearedMrii Crainial Drill
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mri Interventions, Inc. · HBG Drills, Burrs, Trephines & Accessories (Manual)
Cleared on Mar 22, 2013 as substantially equivalent to K961113 (Clinical Neuro Systems, LLC, 1996) after a 221-day review. Its family tree reaches back 1 generation to 1996. 4 later devices descend from it.
- Decided
- Mar 22, 2013
- Review
- 221 days
- Class
- Class II
- Product code
- HBG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K961113 (1996). 4 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK961113 CNS Interchangeable Bit Cranial DrillClinical Neuro Systems, LLC · 1996 · Recalled
- This deviceK122456 Mrii Crainial DrillMri Interventions, Inc. · 2013
- Descendant · cites it directly · 2 of its ownK151536 SmartTwist MRII Hand Drill, SmartTip MRII Drill bit Kit, 4.5mm, 6.0mmMri Interventions, Inc. · 2015
- Descendant · cites it directly · 1 of its ownK160129 MRII Cranial Drill and AccessoriesMri Interventions, Inc. · 2016
- Descendant · cites it directly · 0 of its ownK170442 Cranial Drill Bits and AccessoriesAd-Tech Medical Instrument Corporation · 2017 · Recalled
- Descendant · cites it directly · 0 of its ownK132436 Varioguide Drill KitMri Interventions, Inc. · 2014
Most influential descendants
Showing 4 of 4 · See all- K151536SmartTwist MRII Hand Drill, SmartTip MRII Drill bit Kit, 4.5mm, 6.0mmMri Interventions, Inc. · 2015 · cites it directly2descendants
- K160129MRII Cranial Drill and AccessoriesMri Interventions, Inc. · 2016 · cites it directly1descendant
- K170442Cranial Drill Bits and AccessoriesAd-Tech Medical Instrument Corporation · 2017 · cites it directly0descendants
- K132436Varioguide Drill KitMri Interventions, Inc. · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K961113 | CNS Interchangeable Bit Cranial Drill | Clinical Neuro Systems, LLC | 1996 | 39 |
| 0 (this device) | K122456 | Mrii Crainial Drill | Mri Interventions, Inc. | 2013 | — |
| +1 | K151536 | SmartTwist MRII Hand Drill, SmartTip MRII Drill bit Kit, 4.5mm, 6.0mm | Mri Interventions, Inc. | 2015 | — |
| +1 | K160129 | MRII Cranial Drill and Accessories | Mri Interventions, Inc. | 2016 | — |
| +1 | K170442 | Cranial Drill Bits and Accessories | Ad-Tech Medical Instrument Corporation | 2017 | 2 |
| +1 | K132436 | Varioguide Drill Kit | Mri Interventions, Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 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 HBG? 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 HBG device
- #1 K252696 Legacyscore 12.2 · 7 generations · no Class I recall
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 |
|---|---|---|---|
| * | K961113 | CNS Interchangeable Bit Cranial DrillSummary page 1…Regulation Number: 882.4300 Product Code: HBC 3. Predicate Device Integra Hand Drill, K961 113 4. Intendeded Use Statement: The MRII Cranial Drill and accessories is intended to provide access through… | 1996 |
What descends from it? (4)
4 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 HBG devicesHBG Drills, Burrs, Trephines & Accessories (Manual): FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · HBG
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HBG
Too few HBG 510(k)s in any year since 2007 to give a median.
Recalls per year · HBG
9in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HBG
2in 2025
MAUDE reports naming product code HBG, 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 | — | 1 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 14 | 0 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 1 | — | 0 | 1 |
| 2014 | 0 | — | 14 | 5 |
| 2015 | 1 | — | 0 | 3 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 2 | — | 0 | 6 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 0 | — | 0 | 3 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 3 |
| 2023 | 0 | — | 9 | 3 |
| 2024 | 0 | — | 0 | 11 |
| 2025 | 1 | — | 0 | 2 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
The MRII Cranial Drill and accessories is intended to provide access through the skull for ventriculostomy or other neurological procedures, such as biopsy or catheter placement, in or near an MR scanner of 3T maximum field strength. The MRI Cranial Drill and accessories are intended to be used only when the scanner is not performing a scan. The MRII Cranial Drill is intended for single use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122456 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122456: Mrii Crainial Drill.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122456
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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