Cleared Traditional

K160501 - Noxilizer Surgical Ruler

K160501 is an FDA 510(k) clearance for Noxilizer Surgical Ruler, manufactured by Noxilizer, Inc.. The device is a Class 1 General & Plastic Surgery device with product code FTY cleared through the Traditional 510(k) pathway after a 93-day FDA review.

K160501 · Noxilizer, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K160501

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
22d faster than avg
Panel avg: 115d · This submission: 93d
Pathway characteristics
Predicate-based equivalence.

FTY Device Classification - Class 1, General Controls

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.

Regulatory Peers - FTY Tape, Measuring, Rulers And Calipers

All 17
Devices cleared under the same product code (FTY) and FDA review panel - the closest regulatory comparables to K160501.
DISPOSABLE WOUND MEASURE GUIDE, PLASTIC, PROTECTOR, WOUND, PLASTIC
K951064 · S-E Sales & Distribution, Inc. · May 1995
OLYMPIC AUTO-LENGTH
K934930 · Olympic Medical Corp. · Dec 1993
OLYMPIC INFA-LENGTH
K932112 · Olympic Medical Corp. · Jul 1993
STRYKER PRESSURE MONITOR SYSTEM
K883485 · Stryker Corp. · Sep 1988
PEDIATRIC AIRWAY MEASUREMENT SYSTEM & P.A.M.S.
K880441 · Plane Iii, Inc. · Feb 1988
TUMORIMETER
K874352 · Cancer Technologies, Inc. · Nov 1987
K160501 · Noxilizer Surgical Ruler
Download PDF FDA Summary Noxilizer, Inc.