Cleared Traditional

K162014 - Nellcor Flexible SpO2 Sensor

K162014 is the FDA 510(k) clearance for Nellcor Flexible SpO2 Sensor by Bluepoint Medical GmbH & Co. KG. It is a Class 2 Anesthesiology device (product code DQA) cleared through the Traditional 510(k) pathway after a 200-day FDA review.

K162014 · Bluepoint Medical GmbH & Co. KG · Anesthesiology device
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Feb 2017
Decision
200d
Days
Class 2
Risk

K162014 is an FDA 510(k) clearance for the Nellcor Flexible SpO2 Sensor, Nellcor Flexible SpO2 Sensor, Small, Nellcor Fl.... Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Bluepoint Medical GmbH & Co. KG (Selmsdorf, DE). The FDA issued a Cleared decision on February 6, 2017 after a review of 200 days - an extended review 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: 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.

View all Bluepoint Medical GmbH & Co. KG devices

Submission Details

510(k) Number K162014 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 2016
Decision Date February 06, 2017
Days to Decision 200 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
60d slower than avg
Panel avg: 140d · This submission: 200d
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 369
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K162014.
Pulse Oximeter
K171241 · Hunan Accurate Bio-Medical Technology Co., Ltd. · Mar 2018
Wrist Pulse Oximeter
K172366 · Beijing Choice Electronic Technology Co., Ltd. · Mar 2018
The Nellcor pulse oximetry monitor interface cable
K172482 · Covidien · Dec 2017
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
Masimo Disposable Transflectance Forehead Sensor
K160940 · Masimo Corporation · Nov 2016