510(k) · Cleared
ClearedSmartTwist MRII Hand Drill, SmartTip MRII Drill bit Kit, 4.5mm, 6.0mm
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 Jul 8, 2015 as substantially equivalent to K122456 (Mri Interventions, Inc., 2013) after a 30-day review. Its family tree reaches back 2 generations to 1996. 2 later devices descend from it.
- Decided
- Jul 8, 2015
- Review
- 30 days
- Class
- Class II
- Product code
- HBG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K961113 (1996). 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK961113 CNS Interchangeable Bit Cranial DrillClinical Neuro Systems, LLC · 1996 · Recalled
- 1 generation backK122456 Mrii Crainial DrillMri Interventions, Inc. · 2013
- This deviceK151536 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 · 2 generations on · 0 of its ownK170442 Cranial Drill Bits and AccessoriesAd-Tech Medical Instrument Corporation · 2017 · Recalled
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K961113 | CNS Interchangeable Bit Cranial Drill | Clinical Neuro Systems, LLC | 1996 | 39 |
| −1 | K122456 | Mrii Crainial Drill | Mri Interventions, Inc. | 2013 | — |
| 0 (this device) | 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 | — |
| +2 | K170442 | Cranial Drill Bits and Accessories | Ad-Tech Medical Instrument Corporation | 2017 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K122456 | Mrii Crainial DrillSummary page 5…Regulation Number: 21CFR 882.4300 Product Code: HBG 3. Predicate Device: MRII Cranial Drill, K122456 4. Device Description: The SmartTwist MRII Hand Drill is a hand held manual drill with a 3:1 gear… | 2013 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K160129 | MRII Cranial Drill and Accessories | 2016 | 1 |
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 19 years and passes through 2 companies; a new generation was cleared every 16.8 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K160129 (Mri Interventions, Inc., 2016) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K122456.
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. 2015, 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 SmartTwist™ MRII Hand Drill and accessories are 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 strength. The SmartTwist MRII Hand Drill and accessories are intended to be used only when the scanner is not performing a scan. The SmartTwist MRII Hand Drill is intended for single use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151536 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151536: SmartTwist MRII Hand Drill, SmartTip MRII Drill bit Kit, 4.5mm, 6.0mm.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151536
Report an extraction error
Are you the manufacturer?
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