Cleared Traditional

K180685 - AS-3XX Series Fingertip Pulse Oximeter (FDA 510(k) Clearance)

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

K180685 · Xiamen Acurio Instruments Co., Ltd. · Anesthesiology device
Nov 2018
Decision
259d
Days
Class 2
Risk

K180685 is an FDA 510(k) clearance for the AS-3XX Series Fingertip Pulse Oximeter. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Xiamen Acurio Instruments Co., Ltd. (Xiamen, CN). The FDA issued a Cleared decision on November 29, 2018 after a review of 259 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.

Submission Details

510(k) Number K180685 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 2018
Decision Date November 29, 2018
Days to Decision 259 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
34d slower than avg
Panel avg: 225d · This submission: 259d
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 20
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K180685.
AViTA Pulse Oximeter (SP61)
K252448 · Avita Corporation · Feb 2026
YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310)
K252805 · Jiangsu Yuyue Medical Equipment& Supply Co., Ltd. · Feb 2026
Reusable SPO2 Sensor (BSA307-47
K253109 · Shenzhen Best Electronics Co., Ltd. · Jan 2026
Spo2 Sensor CSS032D
K251751 · Shenzhen Ykd Technology Co., Ltd. · Dec 2025
Unimed Reusable SpO2 Sensors (-08 Series) (U403S-08)
K251691 · Unimed Medical Supplies, Inc. · Dec 2025
Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-48)
K251696 · Unimed Medical Supplies, Inc. · Dec 2025