Cleared Traditional

K230587 - Wrist Pulse Oximeter

K230587 is an FDA 510(k) clearance for Wrist Pulse Oximeter, manufactured by Beijing Choice Electronic Technology Co., Ltd.. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Traditional 510(k) pathway after a 273-day FDA review.

K230587 · Beijing Choice Electronic Technology Co., Ltd. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K230587

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.

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 453
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
Pediarity™
K231531 · Hinlab, Inc. · Dec 2023
Masimo Stork
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