Cleared Traditional

Wrist Pulse Oximeter (K230587) - FDA 510(k) Clearance

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

K230587 · Beijing Choice Electronic Technology Co., Ltd. · Anesthesiology device
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Nov 2023
Decision
273d
Days
Class 2
Risk

K230587 is an FDA 510(k) clearance for the Wrist Pulse Oximeter. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Beijing Choice Electronic Technology Co., Ltd. (Beijing, CN). The FDA issued a Cleared decision on November 30, 2023 after a review of 273 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 Beijing Choice Electronic Technology Co., Ltd. devices

Submission Details

510(k) Number K230587 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 2023
Decision Date November 30, 2023
Days to Decision 273 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
133d slower than avg
Panel avg: 140d · This submission: 273d
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 181
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K230587.
Pulse Oximeter(Model OHT60,OXH78)
K230277 · Cofoe Medical Technology Co., Ltd. · Jan 2024
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K223721 · Masimo Corporation · Dec 2023
Finger Clip Pulse Oximeter
K231243 · Guangdong Genial Technology Co., Ltd. · Oct 2023
Carescape SpO2 - Masimo
K232389 · Masimo Corporation · Sep 2023
circul™ pro Ring
K221361 · Bodimetrics, LLC · Aug 2023