Cleared Traditional

K160865 - Model 6100C Series Single-Patient Use

K160865 is an FDA 510(k) clearance for Model 6100C Series Single-Patient Use, manufactured by Nonin Medical, Inc.. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Traditional 510(k) pathway after a 128-day FDA review.

K160865 · Nonin Medical, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2016
Decision
128d
Days
Class 2
Risk

K160865 is an FDA 510(k) clearance for the Model 6100C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (610.... Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Nonin Medical, Inc. (Plymouth, US). The FDA issued a Cleared decision on August 5, 2016 after a review of 128 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.

View all Nonin Medical, Inc. devices

FDA 510(k) Submission Details - K160865

510(k) Number K160865 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 2016
Decision Date August 05, 2016
Days to Decision 128 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
12d faster than avg
Panel avg: 140d · This submission: 128d
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 K160865.
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
Finger Type Pulse Oximeter
K151024 · Taidoc Technology Corporation · Mar 2016
Masimo MightySat Rx Fingertip Pulse Oximeter
K150314 · Masimo Corporation · Oct 2015
Fingertip Pulse Oximeter
K151206 · Beijing Choice Electronic Technololgy Co., Ltd. · Aug 2015