Cleared Traditional

K183556 - oCare Wrist Pulse Oximeter

K183556 is the FDA 510(k) clearance for oCare Wrist Pulse Oximeter by Taiwan Biophotonic Corporation. It is a Class 2 Anesthesiology device (product code DQA) cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K183556 · Taiwan Biophotonic Corporation · Anesthesiology device
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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.

View all Taiwan Biophotonic Corporation devices

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
83d faster than avg
Panel avg: 140d · 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 367
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K183556.
Masimo Rad-67 Pulse CO-Oximeter and Accessories
K182887 · Masimo Corporation · Mar 2019
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K182822 · Taiwan Aulisa Medical Devices Technologies, Inc. · Mar 2019
Guardian Angel Rx GA2000 Digital Vital Sign Monitoring System
K183067 · Taiwan Aulisa Medical Devices Technologies, Inc. · Mar 2019
Masimo MightySat Rx Fingertip Pulse Oximeter
K181956 · Masimo Corporation · Jan 2019
vital signs monitor
K180380 · Edan Instruments, Inc. · Dec 2018
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K180685 · Xiamen Acurio Instruments Co., Ltd. · Nov 2018