Cleared Traditional

Reusable, Finger Clip Nonin Medical CO-Met Oximetry Sensor (K172625) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through predicate-based substantial equivalence.

K172625 · Nonin Medical, Inc. · Anesthesiology device
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May 2018
Decision
252d
Days
Class 2
Risk

K172625 is an FDA 510(k) clearance for the Reusable, Finger Clip Nonin Medical CO-Met Oximetry Sensor. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Nonin Medical, Inc. (Plymouth, US). The FDA issued a Cleared decision on May 11, 2018 after a review of 252 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 Nonin Medical, Inc. devices

Submission Details

510(k) Number K172625 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 2017
Decision Date May 11, 2018
Days to Decision 252 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
112d slower than avg
Panel avg: 140d · This submission: 252d
Pathway characteristics
Predicate-based equivalence.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Anesthesiology devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT03030833 Completed Observational Industry-sponsored

Dysfunctional Hemoglobin Pulse Oximetry

Dysfunctional Hemoglobin Pulse Oximeter

36
Patients (actual)
1
Site
Condition studied Carbon Monoxide Poisoning
Eligibility All sexes · 18 Years+
Principal investigator David B MacLeod, MD
Sponsor Nonin Medical, Inc (industry)
Started 2017-02-06 → Primary completion 2017-04-30
Primary outcome
Carboxyhemoglobin accuracy
Study completed - no results published. This trial concluded in 2017 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished. Individual participant data will not be shared.
View full study on ClinicalTrials.gov

Regulatory Peers - DQA Oximeter

All 172
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K172625.
Reusable SpO2 Sensors, Disposable SpO2 Sensors
K172981 · APK Technology Co., Ltd. · Jun 2018
Oximeter
K173045 · Shenzhen Greatmade Tech Limited · Jun 2018
Belun Ring
K180174 · Belun Technology Company Limited · May 2018
Pulse Oximeter
K172141 · Shanghai Berry Electronic Tech Co., Ltd. · Apr 2018
Pulse Oximeter
K171241 · Hunan Accurate Bio-Medical Technology Co., Ltd. · Mar 2018
Wrist Pulse Oximeter
K172366 · Beijing Choice Electronic Technology Co., Ltd. · Mar 2018