Cleared Traditional

K183556 - oCare Wrist Pulse Oximeter (FDA 510(k) Clearance)

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

K183556 · Taiwan Biophotonic Corporation · Anesthesiology device
Feb 2019
Decision
57d
Days
Class 2
Risk

K183556 is an FDA 510(k) clearance for the oCare Wrist Pulse Oximeter. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Taiwan Biophotonic Corporation (Zhubei, TW). The FDA issued a Cleared decision on February 15, 2019 after a review of 57 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

Submission Details

510(k) Number K183556 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 2018
Decision Date February 15, 2019
Days to Decision 57 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
168d faster than avg
Panel avg: 225d · This submission: 57d
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 K183556.
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