Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Clinical Neuro Systems, LLC — Predicate Candidate Screening

5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

69 daysmedian FDA review time

77 days90th percentile

5clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K961113	CNS INTERCHANGEABLE BIT CRANIAL DRILL	Clinical Neuro Systems, LLC	1996-06-05	77	39
K930229	CLINICAL NEURO SYSTEMS CRANIAL DRILL	Clinical Neuro Systems, LLC	1993-03-16	56	0
K922941	CLINICAL NEURO SYSTEMS MONITORR ICP VENTRICULAR CA	Clinical Neuro Systems, LLC	1992-08-26	69	0
K922936	CLINICAL NEURO SYSTEMS MONITORR ICP LUMBAR CATHETE	Clinical Neuro Systems, LLC	1992-08-26	69	0
K920156	CLINICAL NEURO SYST MONITORR EXT CSF DRAIN/MONI SY	Clinical Neuro Systems, LLC	1992-03-16	62	1

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda