Cleared Traditional

K160501 - Noxilizer Surgical Ruler (FDA 510(k) Clearance)

Class I General & Plastic Surgery device.

K160501 · Noxilizer, Inc. · General & Plastic Surgery device
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May 2016
Decision
93d
Days
Class 1
Risk

K160501 is an FDA 510(k) clearance for the Noxilizer Surgical Ruler. Classified as Tape, Measuring, Rulers And Calipers (product code FTY), Class I - General Controls.

Submitted by Noxilizer, Inc. (Baltimore, US). The FDA issued a Cleared decision on May 26, 2016 after a review of 93 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4800 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Noxilizer, Inc. devices

Submission Details

510(k) Number K160501 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 2016
Decision Date May 26, 2016
Days to Decision 93 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
21d faster than avg
Panel avg: 114d · This submission: 93d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FTY Tape, Measuring, Rulers And Calipers
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4800
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.