Cleared Traditional

K141024 - EXTERNAL PULSE OXIMETER

K141024 is an FDA 510(k) clearance for EXTERNAL PULSE OXIMETER, manufactured by Beijing Choice Electronic Technololgy Co., Ltd.. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Traditional 510(k) pathway after a 267-day FDA review.

K141024 · Beijing Choice Electronic Technololgy Co., Ltd. · Anesthesiology device
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Jan 2015
Decision
267d
Days
Class 2
Risk

K141024 is an FDA 510(k) clearance for the EXTERNAL PULSE OXIMETER. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Beijing Choice Electronic Technololgy Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on January 13, 2015 after a review of 267 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 Technololgy Co., Ltd. devices

FDA 510(k) Submission Details - K141024

510(k) Number K141024 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 21, 2014
Decision Date January 13, 2015
Days to Decision 267 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
127d slower than avg
Panel avg: 140d · This submission: 267d
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 613
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K141024.
Fingertip Pulse Oximeter
K142888 · Beijing Choice Electronic Technololgy Co., Ltd. · Feb 2015
Unimed Disposable and Reusable SPO2 Sensors
K142832 · Unimed Medical Supplies, Inc. · Feb 2015
Pulse oximeter NBM-200
K142209 · Orsense, Ltd. · Jan 2015
PULSE OXIMETER
K141105 · Hunan Accurate Bio-Medical Technology Co., Ltd. · Dec 2014
NELLCOR PORTABLE SPO2 PATIENT MONITORING SYSTEM ( NPSPMS )
K141542 · Covidien, LLC · Oct 2014
FINGERTIP PULSE OXIMETER
K140582 · Shenzhen Jumper Medical Equipment Co., Ltd. · Aug 2014