Cleared Traditional

K240215 - BLUE 400 (FDA 510(k) Clearance)

Also includes:
BLUE 400 S

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K240215 · Carl Zeiss Meditec, AG · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2024
Decision
154d
Days
Class 2
Risk

K240215 is an FDA 510(k) clearance for the BLUE 400. Classified as Diagnostic Neurosurgical Microscope Filter (product code QFX), Class II - Special Controls.

Submitted by Carl Zeiss Meditec, AG (Oberkochen, DE). The FDA issued a Cleared decision on June 28, 2024 after a review of 154 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4950 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Carl Zeiss Meditec, AG devices

Submission Details

510(k) Number K240215 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 26, 2024
Decision Date June 28, 2024
Days to Decision 154 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
6d slower than avg
Panel avg: 148d · This submission: 154d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QFX Diagnostic Neurosurgical Microscope Filter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4950
Definition A Diagnostic Neurosurgical Microscope Filter Is A Device Intended For Use During Neurosurgery To Visualize Fluorescence And Enhance Visualization Of Tissue Associated With A Specific Disease Or Condition.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Consultant

Carl Zeiss Meditec, Inc.
Chaitali Gawde

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.