Cleared Traditional

NORDIX INC RECHARGEABLE BATTERY PART NUMBER 2116 (K013133) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K013133 · Nordix, Inc. · General & Plastic Surgery device
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Nov 2001
Decision
55d
Days
Class 1
Risk

K013133 is an FDA 510(k) clearance for the NORDIX INC RECHARGEABLE BATTERY PART NUMBER 2116. Classified as Battery, Replacement, Rechargeable (product code MOQ), Class I - General Controls.

Submitted by Nordix, Inc. (Phoenix, US). The FDA issued a Cleared decision on November 13, 2001 after a review of 55 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4820 - the FDA general and plastic surgery 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 Nordix, Inc. devices

Submission Details

510(k) Number K013133 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 2001
Decision Date November 13, 2001
Days to Decision 55 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 115d · This submission: 55d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MOQ Battery, Replacement, Rechargeable
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4820
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.