510(k) Report

510(k) · Cleared

Recalled · Class II · 2024

CNS Interchangeable Bit Cranial Drill

K961113510(k) TraditionalCleared Jun 5, 199677-day reviewClass II21 CFR 882.4300Recalls 39

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Clinical Neuro Systems, LLC · HBG Drills, Burrs, Trephines & Accessories (Manual)

Cleared on Jun 5, 1996 after a 77-day review. The FDA summary names its predicate without a number. 7 later devices descend from it. It has been recalled 39 times.

Decided
Jun 5, 1996
Review
77 days
Class
Class II
Product code
HBG
Recalls
39
Predicates
0

7 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2025: 2 descendants cleared2013: 1 descendant cleared2016: 1 descendant cleared2017: 1 descendant cleared2015: 1 descendant cleared2014: 1 descendant cleared1995200020052010201520202025
  1. This deviceK961113 CNS Interchangeable Bit Cranial DrillClinical Neuro Systems, LLC · 1996
  2. Descendant · cites it directly · 4 of its ownK122456 Mrii Crainial DrillMri Interventions, Inc. · 2013
  3. Descendant · 2 generations on · 2 of its ownK151536 SmartTwist MRII Hand Drill, SmartTip MRII Drill bit Kit, 4.5mm, 6.0mmMri Interventions, Inc. · 2015
  4. Descendant · 2 generations on · 1 of its ownK160129 MRII Cranial Drill and AccessoriesMri Interventions, Inc. · 2016
  5. Descendant · cites it directly · 0 of its ownK252696 LegacyPhasor Health, LLC · 2025
  6. Descendant · cites it directly · 0 of its ownK252514 Evac-MriPhasor Health, LLC · 2025

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2013: 12014: 12015: 12016: 12017: 12025: 2
2013high 2 (2025) · low 0 (2018)2026

Most influential descendants

Showing 5 of 7 · See all
  • K122456Mrii Crainial DrillMri Interventions, Inc. · 2013 · cites it directly4descendants
  • K151536SmartTwist MRII Hand Drill, SmartTip MRII Drill bit Kit, 4.5mm, 6.0mmMri Interventions, Inc. · 2015 · 2 generations on2descendants
  • K160129MRII Cranial Drill and AccessoriesMri Interventions, Inc. · 2016 · 2 generations on1descendant
  • K252696LegacyPhasor Health, LLC · 2025 · cites it directly0descendants
  • K252514Evac-MriPhasor Health, LLC · 2025 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K961113CNS Interchangeable Bit Cranial DrillClinical Neuro Systems, LLC1996—
+1K122456Mrii Crainial DrillMri Interventions, Inc.2013—
+2K151536SmartTwist MRII Hand Drill, SmartTip MRII Drill bit Kit, 4.5mm, 6.0mmMri Interventions, Inc.2015—
+2K160129MRII Cranial Drill and AccessoriesMri Interventions, Inc.2016—
+1K252696LegacyPhasor Health, LLC2025—
+1K252514Evac-MriPhasor Health, LLC2025—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201310
201410
201510
201610
201710
202520
FIG. 1 — Lineage of K961113, 1996–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K252696 Legacyscore 12.2 · 7 generations · no Class I recall
Get a 510(k) Report

What was it cleared against? (3)

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.

TypeNumberDeviceApplicantDecidedRecalls
*—PS Medical Ventriculostomy Kit: Cranial Drill
Named without a submission number
—
*—Camino Laboratories Twist Drill Procedure Kit: Cranial Drill
Named without a submission number
—
*—Clinical Neuro Systems Cranial Drill
Named without a submission number
—

What descends from it? (7)

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K122456Mrii Crainial DrillMri Interventions, Inc.20134
K252696LegacyPhasor Health, LLC20250
K252514Evac-MriPhasor Health, LLC20250

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Apr 17, 2024Class IIZ-1873-2024Process controlPotential holes and tears in the sterile packaging (header bag) of the Cranial Access Kit may compromise the sterility of the device.
Jan 19, 2024Class IIZ-1197-2024Process controlA defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility maybe compromised.
Jan 19, 2024Class IIZ-1199-2024Process controlA defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility maybe compromised.
Jan 19, 2024Class IIZ-1201-2024Process controlA defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility maybe compromised.
Jan 19, 2024Class IIZ-1200-2024Process controlA defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility maybe compromised.
Jan 19, 2024Class IIZ-1196-2024Process controlA defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility maybe compromised.
Jan 19, 2024Class IIZ-1194-2024Process controlA defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility maybe compromised.
Jan 19, 2024Class IIZ-1203-2024Process controlA defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility maybe compromised.
Jan 19, 2024Class IIZ-1195-2024Process controlA defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility maybe compromised.
Jan 19, 2024Class IIZ-1193-2024Process controlA defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility maybe compromised.
Jan 19, 2024Class IIZ-1198-2024Process controlA defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility maybe compromised.
Jan 19, 2024Class IIZ-1202-2024Process controlA defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility maybe compromised.
Oct 19, 2023Class IIZ-0492-2024Process controlDefect in the outer packaging of the Cranial Access Kits can cause the packaging to split without any additional forces outside compromising the sterility of the device
Oct 19, 2023Class IIZ-0493-2024Process controlDefect in the outer packaging of the Cranial Access Kits. can cause the packaging to split without any additional forces outside compromising the sterility of the device
Oct 19, 2023Class IIZ-0494-2024Process controlDefect in the outer packaging of the Cranial Access Kits. can cause the packaging to split without any additional forces outside compromising the sterility of the device
Oct 19, 2023Class IIZ-0495-2024Process controlDefect in the outer packaging of the Cranial Access Kits. can cause the packaging to split without any additional forces outside compromising the sterility of the device
Oct 19, 2023Class IIZ-0496-2024Process controlDefect in the outer packaging of the Cranial Access Kits. can cause the packaging to split without any additional forces outside compromising the sterility of the device
Oct 19, 2023Class IIZ-0491-2024Process controlDefect in the outer packaging of the Cranial Access Kits can cause the packaging to split without any additional forces outside compromising the sterility of the device
Oct 19, 2023Class IIZ-0499-2024Process controlDefect in the outer packaging of the Cranial Access Kits. can cause the packaging to split without any additional forces outside compromising the sterility of the device
Oct 19, 2023Class IIZ-0497-2024Process controlDefect in the outer packaging of the Cranial Access Kits. can cause the packaging to split without any additional forces outside compromising the sterility of the device
Oct 19, 2023Class IIZ-0498-2024Process controlDefect in the outer packaging of the Cranial Access Kits. can cause the packaging to split without any additional forces outside compromising the sterility of the device
Aug 24, 2016Class IIZ-2733-2016PackagingIntegra LifeSciences has been notified of a medical device recall by Adaptive Surgical, LLC involving their Riverlon" Nylon 3-0 Sutures that are packaged in Integras Cranial Access Kits. It was found that product seals may become open…
Sep 4, 2013Class IIZ-2260-2013PackagingIntegra is recalling certain lots of Cranial Access Kit due to a possibility that the seal integrity of the sterile package may become compromised during shipping.
Dec 21, 2011Not classifiedZ-0749-2012Labeling False and MisleadingCurrent package insert was revised to include additional warning information related to the potential hazards of an unapproved off-label use of Xylocaine.
Dec 21, 2011Not classifiedZ-0750-2012Labeling False and MisleadingCurrent package insert was revised to include additional warning information related to the potential hazards of an unapproved off-label use of Xylocaine.
Dec 21, 2011Not classifiedZ-0752-2012Labeling False and MisleadingCurrent package insert was revised to include additional warning information related to the potential hazards of an unapproved off-label use of Xylocaine.
Dec 21, 2011Not classifiedZ-0756-2012Labeling False and MisleadingCurrent package insert was revised to include additional warning information related to the potential hazards of an unapproved off-label use of Xylocaine.
Dec 21, 2011Not classifiedZ-0757-2012Labeling False and MisleadingCurrent package insert was revised to include additional warning information related to the potential hazards of an unapproved off-label use of Xylocaine.
Dec 21, 2011Not classifiedZ-0748-2012Labeling False and MisleadingCurrent package insert was revised to include additional warning information related to the potential hazards of an unapproved off-label use of Xylocaine.
Dec 21, 2011Not classifiedZ-0751-2012Labeling False and MisleadingCurrent package insert was revised to include additional warning information related to the potential hazards of an unapproved off-label use of Xylocaine.
Dec 21, 2011Not classifiedZ-0755-2012Labeling False and MisleadingCurrent package insert was revised to include additional warning information related to the potential hazards of an unapproved off-label use of Xylocaine.
Dec 21, 2011Not classifiedZ-0758-2012Labeling False and MisleadingCurrent package insert was revised to include additional warning information related to the potential hazards of an unapproved off-label use of Xylocaine.
Dec 21, 2011Not classifiedZ-0759-2012Labeling False and MisleadingCurrent package insert was revised to include additional warning information related to the potential hazards of an unapproved off-label use of Xylocaine.
Dec 21, 2011Not classifiedZ-0753-2012Labeling False and MisleadingCurrent package insert was revised to include additional warning information related to the potential hazards of an unapproved off-label use of Xylocaine.
Dec 21, 2011Not classifiedZ-0754-2012Labeling False and MisleadingCurrent package insert was revised to include additional warning information related to the potential hazards of an unapproved off-label use of Xylocaine.
Feb 22, 2011Not classifiedZ-2194-2011Labeling mix-upsOuter packaging of Combo Kit was mislabeled with an incorrect lot number.
Feb 22, 2011Not classifiedZ-2171-2011Error in labelingOuter box of Monitoring Kit was mislabeled with the incorrect part number.
Jul 13, 2009Not classifiedZ-2084-2009Packaging process controlLack of packaging seal integrity on various pain management kits may compromise sterility of contents.
Mar 19, 2003Not classifiedZ-1097-04OtherThe outer labeling of the convenience kit indicates that an additional bottle of Sodium Chloride (saline) solution is included in the Custom Kit 31176; however, an additional bottle of 1% Xylocaine was included in the Custom Kit.

The 5 latest of 39 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K122456 (Mri Interventions, Inc., 2013) has gone furthest, with 4 descendants of its own.

How does its category compare?

All HBG devices

HBG Drills, Burrs, Trephines & Accessories (Manual): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HBG

1in 2025

2013: 12015: 12016: 12017: 22025: 1
2007high 2 (2017) · low 0 (2007)2026

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

2009: 12011: 142014: 142023: 92026 (partial year): 1
2007high 14 (2011) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HBG

2in 2025

2012: 12013: 12014: 52015: 32017: 62018: 22019: 32021: 12022: 32023: 32024: 112025: 2
2007high 11 (2024) · low 0 (2007)2025

MAUDE reports naming product code HBG, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—10
20100—00
20110—140
20120—01
20131—01
20140—145
20151—03
20161—00
20172—06
20180—02
20190—03
20200—00
20210—01
20220—03
20230—93
20240—011
20251—02
20260—1—

What is it indicated for?

The drill is intended to be used with an external drainage and monitoring system in selected patients to reduce intracranial pressure (ICP), to monitor CSF, to provide temporary drainage of CSF, and to monitor ICP. The drill is intended for single use only.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Clinical Neuro Systems, LLC

5 FDA decisions under this applicant name. See the company

  • K930229Clinical Neuro Systems Cranial DrillClinical Neuro Systems, LLC · 1993
  • K922936Clinical Neuro Systems Monitorr Icp Lumbar CatheteClinical Neuro Systems, LLC · 1992
  • K922941Clinical Neuro Systems Monitorr Icp Ventricular CAClinical Neuro Systems, LLC · 1992
  • K920156Clinical Neuro Syst Monitorr Ext CSF Drain/Moni SYClinical Neuro Systems, LLC · 19921 Class I recall

Recent decisions in HBG

The HBG category page

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  • K153587Taps for Resorbable ScrewsSynthes (USA) Products, LLC · 2017
  • K162884SpineGuard DSG Zavation Screw SystemSpineguard S.A. · 2017
  • K160129MRII Cranial Drill and AccessoriesMri Interventions, Inc. · 2016
  • K151536SmartTwist MRII Hand Drill, SmartTip MRII Drill bit Kit, 4.5mm, 6.0mmMri Interventions, Inc. · 2015

https://510kreport.com/device/K961113 · printed Nov 5, 2026

Cite this page

510(k) Report. “K961113: CNS Interchangeable Bit Cranial Drill.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K961113

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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