510(k) Report

FDA applicant

Clinical Neuro Systems, LLC

Santa Barbara, CA5 decisions1992–199640 recalls

FDA records 5 decisions for Clinical Neuro Systems, LLC (Santa Barbara, CA) from 1992 to 1996: 5 510(k) clearances. Most are in product codes JXG (Shunt, Central Nervous System And Components) and HBG (Drills, Burrs, Trephines & Accessories (Manual)). 40 recalls are linked to its devices, 1 Class I.

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

FIG. A — Illustration, neurology panel, where it files most

How often FDA has decided Clinical Neuro Systems, LLC’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Clinical Neuro Systems, LLC since 2007.

Recalls per year

12in 2024

2009: 12011: 142013: 12016: 12019: 1, 1 Class I2023: 92024: 12
2007high 14 (2011) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Clinical Neuro Systems, LLC by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Clinical Neuro Systems, LLC’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • JXGShunt, Central Nervous System And Components3decisions
  • HBGDrills, Burrs, Trephines & Accessories (Manual)1decision
  • HBEDrills, Burrs, Trephines & Accessories (Simple, Powered)1decision

Who builds on its devices?

Later devices cite its devices 8 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K920156Clinical Neuro Syst Monitorr Ext CSF Drain/Moni SYClinical Neuro Systems, LLC · 19924cite it
  • K961113CNS Interchangeable Bit Cranial DrillClinical Neuro Systems, LLC · 19963cite it
  • K922941Clinical Neuro Systems Monitorr Icp Ventricular CAClinical Neuro Systems, LLC · 19921cites it

What has FDA decided for it lately?

  • K961113CNS Interchangeable Bit Cranial DrillClinical Neuro Systems, LLC · 199639 recalls
  • 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

All 5 as Clinical Neuro Systems, LLC →

What has been recalled?

40 recalls linked to its devices; the latest:

  • K961113Integra¿ Cranial access kit (without Prep solutions) Bit and Guard- Used during a…Apr 17, 2024Class II
  • K961113Ref No: INS7250 / Integra Cranial Access Kit. For access to the subarachnoid space or…Jan 19, 2024Class II
  • K961113Ref No: INS7270 / Integra¿ Cranial Access Kit. For access to the subarachnoid space or…Jan 19, 2024Class II
  • K961113Ref No: INSHITH / Integra¿ Cranial Access Kit. For access to the subarachnoid space or…Jan 19, 2024Class II
  • K961113INS7280 / Integra¿ Cranial Access Kit. For access to the subarachnoid space or the…Jan 19, 2024Class II
  • K961113Ref No: INS5HND / Integra Cranial access kit (without Prep solutions) Bit and Guard. For…Jan 19, 2024Class II