Cleared Traditional

GE ApexPro CH SpO2 - Nellcor Cable, GE ApexPro FH SpO2 - Nellcor Cable (K201179) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K201179 · Covidien, LLC · Anesthesiology device
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Jul 2020
Decision
80d
Days
Class 2
Risk

K201179 is an FDA 510(k) clearance for the GE ApexPro CH SpO2 - Nellcor Cable, GE ApexPro FH SpO2 - Nellcor Cable. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Covidien, LLC (Boulder, US). The FDA issued a Cleared decision on July 20, 2020 after a review of 80 days - a notably fast clearance cycle.

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: 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 Covidien, LLC devices

Submission Details

510(k) Number K201179 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 2020
Decision Date July 20, 2020
Days to Decision 80 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
60d faster than avg
Panel avg: 140d · This submission: 80d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 170
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K201179.
Masimo Rad-G Pulse Oximeter, Masimo Rad-G YI sensor, Masimo Rad-G Reusable sensor
K201770 · Masimo Corporation · Sep 2020
Pulse Oximeter
K200414 · Shenzhen Aeon Technology Co., Ltd. · Sep 2020
Reusable and Disposable SpO2 Sensors
K201360 · Xinkang Medical Instrument Co. , Ltd. · Aug 2020
Oxxiom
K200537 · True Wearables, Inc. · Jul 2020
H500 Multi-Sensing Oximetry System
K192900 · Nonin Medical, Inc. · Jun 2020
Leadtek Fingertip Pulse Oximeter
K193350 · Leadtek Research, Inc. · Apr 2020