Cleared Traditional

Pulse Oximeter (K171241) - FDA 510(k) Clearance

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

K171241 · Hunan Accurate Bio-Medical Technology Co., Ltd. · Anesthesiology device
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Mar 2018
Decision
334d
Days
Class 2
Risk

K171241 is an FDA 510(k) clearance for the Pulse Oximeter. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Hunan Accurate Bio-Medical Technology Co., Ltd. (Changsha, CN). The FDA issued a Cleared decision on March 27, 2018 after a review of 334 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Hunan Accurate Bio-Medical Technology Co., Ltd. devices

Submission Details

510(k) Number K171241 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 2017
Decision Date March 27, 2018
Days to Decision 334 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
194d slower than avg
Panel avg: 140d · This submission: 334d
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 181
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K171241.
Belun Ring
K180174 · Belun Technology Company Limited · May 2018
Reusable, Finger Clip Nonin Medical CO-Met Oximetry Sensor
K172625 · Nonin Medical, Inc. · May 2018
Pulse Oximeter
K172141 · Shanghai Berry Electronic Tech Co., Ltd. · Apr 2018
Wrist Pulse Oximeter
K172366 · Beijing Choice Electronic Technology Co., Ltd. · Mar 2018
The Nellcor pulse oximetry monitor interface cable
K172482 · Covidien · Dec 2017
Finger Type Pulse Oximeter
K151024 · Taidoc Technology Corporation · Mar 2016