Cleared Special

K123871 - FINGERTIP PULSE OXIMETER

K123871 is the FDA 510(k) clearance for FINGERTIP PULSE OXIMETER by Beijing Choice Electronic Technololgy Co., Ltd.. It is a Class 2 Anesthesiology device (product code DQA) cleared through the Special 510(k) pathway after a 144-day FDA review.

K123871 · Beijing Choice Electronic Technololgy Co., Ltd. · Anesthesiology device
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May 2013
Decision
144d
Days
Class 2
Risk

K123871 is an FDA 510(k) clearance for the FINGERTIP PULSE OXIMETER. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Beijing Choice Electronic Technololgy Co., Ltd. (Shijingshan District, Beijing, CN). The FDA issued a Cleared decision on May 10, 2013 after a review of 144 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 870.2700 - the FDA anesthesiology and respiratory device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Beijing Choice Electronic Technololgy Co., Ltd. devices

Submission Details

510(k) Number K123871 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 2012
Decision Date May 10, 2013
Days to Decision 144 days
Submission Type Special
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
4d slower than avg
Panel avg: 140d · This submission: 144d
Pathway characteristics
Modification to existing cleared device.

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 403
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K123871.
PULSE OXIMETER
K131021 · Nonin Medical, Inc. · Sep 2013
IHEALTH FINGERTIP PULSE OXIMETER
K131111 · Andon Health Co, Ltd. · Sep 2013
VITAL SIGNS MONITOR
K131818 · Edan Instruments, Inc. · Aug 2013
MASIMO RAS-125C ACOUSTIC RESPIRATION SENSOR
K120984 · Masimo Corporation · Apr 2013
WRIST PULSE OXIMETER
K122046 · Beijing Choice Electronic Technololgy Co., Ltd. · Feb 2013
FINGERTIP PULSE OXIMETER
K121697 · Andon Health Co, Ltd. · Oct 2012