Cleared Traditional

K172482 - The Nellcor pulse oximetry monitor inte...

K172482 is an FDA 510(k) clearance for The Nellcor pulse oximetry monitor inte..., manufactured by Covidien. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Traditional 510(k) pathway after a 121-day FDA review.

K172482 · Covidien · Anesthesiology device
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Dec 2017
Decision
121d
Days
Class 2
Risk

K172482 is an FDA 510(k) clearance for the The Nellcor pulse oximetry monitor interface cable. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Covidien (Boulder, US). The FDA issued a Cleared decision on December 15, 2017 after a review of 121 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 870.2700 - the FDA anesthesiology and respiratory 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 Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

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FDA 510(k) Submission Details - K172482

510(k) Number K172482 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 2017
Decision Date December 15, 2017
Days to Decision 121 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
19d faster than avg
Panel avg: 140d · This submission: 121d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQA Device Classification - Class 2, Special Controls

Product Code DQA Oximeter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2700
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 Anesthesiology devices follow this clearance model.

Regulatory Peers - DQA Oximeter

All 453
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K172482.
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K172366 · Beijing Choice Electronic Technology Co., Ltd. · Mar 2018
Masimo Rainbow SET Intellivue Module Pulse CO-Oximeter
K162675 · Masimo Corporation · Dec 2016
Model X-100C CO-Met™ Oximetry System
K160231 · Nonin Medical, Inc. · Dec 2016
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K160940 · Masimo Corporation · Nov 2016