Cleared Traditional

K033621 - NDI PASSIVE SPHERES

K033621 is an FDA 510(k) clearance for NDI PASSIVE SPHERES, manufactured by Northern Digital, Inc.. The device is a Class 2 Neurology device with product code HAW cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K033621 · Northern Digital, Inc. · Neurology device
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Jan 2004
Decision
70d
Days
Class 2
Risk

K033621 is an FDA 510(k) clearance for the NDI PASSIVE SPHERES. Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by Northern Digital, Inc. (Dundas, CA). The FDA issued a Cleared decision on January 27, 2004 after a review of 70 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4560 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Northern Digital, Inc. devices

FDA 510(k) Submission Details - K033621

510(k) Number K033621 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 2003
Decision Date January 27, 2004
Days to Decision 70 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
78d faster than avg
Panel avg: 148d · This submission: 70d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HAW Device Classification - Class 2, Special Controls

Product Code HAW Neurological Stereotaxic Instrument
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4560
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 Peers - HAW Neurological Stereotaxic Instrument

All 310
Devices cleared under the same product code (HAW) and FDA review panel - the closest regulatory comparables to K033621.
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K031770 · Brainlab AG · Aug 2003