Cleared Traditional

K893874 - FUJITENS III

K893874 is an FDA 510(k) clearance for FUJITENS III, manufactured by Altoona Medical Supply. The device is a Class 2 Neurology device with product code GZQ cleared through the Traditional 510(k) pathway after a 210-day FDA review.

K893874 · Altoona Medical Supply · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1989
Decision
210d
Days
Class 2
Risk

K893874 is an FDA 510(k) clearance for the FUJITENS III. Classified as Instrument, Dowel Cutting (product code GZQ), Class II - Special Controls.

Submitted by Altoona Medical Supply (Altoona, US). The FDA issued a Cleared decision on December 22, 1989 after a review of 210 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4275 - 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 Altoona Medical Supply devices

FDA 510(k) Submission Details - K893874

510(k) Number K893874 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 26, 1989
Decision Date December 22, 1989
Days to Decision 210 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
62d slower than avg
Panel avg: 148d · This submission: 210d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GZQ Device Classification - Class 2, Special Controls

Product Code GZQ Instrument, Dowel Cutting
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4275
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.