Cleared Traditional

K162014 - Nellcor Flexible SpO2 Sensor, Nellcor Flexible SpO2 Sensor, Small, Nellcor Flexible SpO2 Sensor, Home Care (same sensor as above, Home Use Guide incl.), Nellcor Flexible SpO2 Sensor, Small, Home Care (same sensor as above, Home Use Guide incl.)

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

K162014 · Bluepoint Medical GmbH & Co. KG · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K162014

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
Combination Product No
PCCP Authorized No
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.

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 Consultant

Imagenix, Inc.
STEPHEN GORSKI

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - DQA Oximeter

All 576
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K162014.
Oxitone 1000
K163382 · Oxitone Medical , Ltd. · May 2017
Fingertip Pulse Oximeter
K161938 · Xuzhou Yongkang Electronic Science Technology Co., Ltd. · May 2017
Guardian Angel GA1000 Digital Vital Sign Monitoring System
K162580 · Taiwan Aulisa Medical Devices Technologies, Inc. · Mar 2017
Caremed Reusable & Disposable SPO2 Sensors
K153184 · Shenzhen Caremed Medical Technology Co., Ltd. · Jan 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