Cleared Traditional

K983092 - TRITON HUDSON CHUCK ATTACHMENT

K983092 is an FDA 510(k) clearance for TRITON HUDSON CHUCK ATTACHMENT, manufactured by Mednext, Inc.. The device is a Class 2 Neurology device with product code HBB cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K983092 · Mednext, Inc. · Neurology device
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Nov 1998
Decision
64d
Days
Class 2
Risk

K983092 is an FDA 510(k) clearance for the TRITON HUDSON CHUCK ATTACHMENT. Classified as Motor, Drill, Pneumatic (product code HBB), Class II - Special Controls.

Submitted by Mednext, Inc. (West Palm Beach, US). The FDA issued a Cleared decision on November 6, 1998 after a review of 64 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4370 - 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 Mednext, Inc. devices

FDA 510(k) Submission Details - K983092

510(k) Number K983092 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 1998
Decision Date November 06, 1998
Days to Decision 64 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
84d faster than avg
Panel avg: 148d · This submission: 64d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HBB Device Classification - Class 2, Special Controls

Product Code HBB Motor, Drill, Pneumatic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4370
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 - HBB Motor, Drill, Pneumatic

All 23
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