Cleared Traditional

K141128 - FINGERTIP PULSE OXIMETER

K141128 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 Traditional 510(k) pathway after a 104-day FDA review.

K141128 · Beijing Choice Electronic Technololgy Co., Ltd. · Anesthesiology device
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Aug 2014
Decision
104d
Days
Class 2
Risk

K141128 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. (Beijing, CN). The FDA issued a Cleared decision on August 13, 2014 after a review of 104 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. 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

Submission Details

510(k) Number K141128 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 2014
Decision Date August 13, 2014
Days to Decision 104 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
36d faster than avg
Panel avg: 140d · This submission: 104d
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 403
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K141128.
Fingertip Pulse Oximeter
K142888 · Beijing Choice Electronic Technololgy Co., Ltd. · Feb 2015
EXTERNAL PULSE OXIMETER
K141024 · Beijing Choice Electronic Technololgy Co., Ltd. · Jan 2015
NELLCOR PORTABLE SPO2 PATIENT MONITORING SYSTEM ( NPSPMS )
K141542 · Covidien, LLC · Oct 2014
FINGERTIP PULSE OXIMETER
K140682 · Beijing Choice Electronic Technololgy Co., Ltd. · Jul 2014
PULSE OXIMETER
K140785 · Nonin Medical, Inc. · Jul 2014
SENSMART MODEL X-100 UNIVERAL OXIMETRY SYSTEM
K132402 · Nonin Medical, Inc. · Feb 2014