Cleared Traditional

K211632 - Pulse Oximeter (FRO-200, FRO-201, FRO-202, FRO-203, FRO-204, FRO-100, FRO-101, FRO-102, FRO-103, FRO-104) (FDA 510(k) Clearance)

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

K211632 · Shenzhen Narig Bio-Medical Technology Co., Ltd. · Anesthesiology device
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Jan 2022
Decision
232d
Days
Class 2
Risk

K211632 is an FDA 510(k) clearance for the Pulse Oximeter (FRO-200, FRO-201, FRO-202, FRO-203, FRO-204, FRO-100, FRO-101.... Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Shenzhen Narig Bio-Medical Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on January 14, 2022 after a review of 232 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 Shenzhen Narig Bio-Medical Technology Co., Ltd. devices

Submission Details

510(k) Number K211632 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 27, 2021
Decision Date January 14, 2022
Days to Decision 232 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
93d slower than avg
Panel avg: 139d · This submission: 232d
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 723
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K211632.
Nasal Alar SpO2 Sensor (989803205381)
K253887 · Philips Medizin Systeme · May 2026
Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)
K260931 · Unimed Medical Supplies, Inc. · Apr 2026
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