Cleared Traditional

K110644 - PRAEZIS PLUS

K110644 is an FDA 510(k) clearance for PRAEZIS PLUS, manufactured by Tatramed Spol. S.R.O.. The device is a Class 2 Neurology device with product code HAW cleared through the Traditional 510(k) pathway after a 444-day FDA review.

K110644 · Tatramed Spol. S.R.O. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2012
Decision
444d
Days
Class 2
Risk

K110644 is an FDA 510(k) clearance for the PRAEZIS PLUS. Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by Tatramed Spol. S.R.O. (Austin, US). The FDA issued a Cleared decision on May 24, 2012 after a review of 444 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Neurology submissions.

View all Tatramed Spol. S.R.O. devices

FDA 510(k) Submission Details - K110644

510(k) Number K110644 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 2011
Decision Date May 24, 2012
Days to Decision 444 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
296d slower than avg
Panel avg: 148d · This submission: 444d
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.

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All 331
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