Cleared Traditional

K180685 - AS-3XX Series Fingertip Pulse Oximeter

K180685 is an FDA 510(k) clearance for AS-3XX Series Fingertip Pulse Oximeter, manufactured by Xiamen Acurio Instruments Co., Ltd.. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Traditional 510(k) pathway after a 259-day FDA review.

K180685 · Xiamen Acurio Instruments Co., Ltd. · Anesthesiology device
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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.

View all Xiamen Acurio Instruments Co., Ltd. devices

FDA 510(k) Submission Details - K180685

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
119d slower than avg
Panel avg: 140d · This submission: 259d
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 576
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K180685.
oCare Wrist Pulse Oximeter
K183556 · Taiwan Biophotonic Corporation · Feb 2019
Masimo MightySat Rx Fingertip Pulse Oximeter
K181956 · Masimo Corporation · Jan 2019
vital signs monitor
K180380 · Edan Instruments, Inc. · Dec 2018
Handheld Pulse Oximeter, Model SP-20
K172792 · Shenzhen Creative Industry Co., Ltd. · Nov 2018
Masimo Rad-97 and Accessories
K180046 · Masimo Corporation · Oct 2018
Fingertip Pulse Oximeter
K181503 · Beijing Choice Electronic Technology Co., Ltd. · Oct 2018