Cleared Traditional

K122046 - WRIST PULSE OXIMETER

K122046 is the FDA 510(k) clearance for WRIST 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 207-day FDA review.

K122046 · Beijing Choice Electronic Technololgy Co., Ltd. · Anesthesiology device
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Feb 2013
Decision
207d
Days
Class 2
Risk

K122046 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 Technololgy Co., Ltd. (Beijing, CN). The FDA issued a Cleared decision on February 4, 2013 after a review of 207 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

Submission Details

510(k) Number K122046 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 2012
Decision Date February 04, 2013
Days to Decision 207 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
67d slower than avg
Panel avg: 140d · This submission: 207d
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 K122046.
VITAL SIGNS MONITOR
K131818 · Edan Instruments, Inc. · Aug 2013
FINGERTIP PULSE OXIMETER
K123871 · Beijing Choice Electronic Technololgy Co., Ltd. · May 2013
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K120984 · Masimo Corporation · Apr 2013
FINGERTIP PULSE OXIMETER
K121697 · Andon Health Co, Ltd. · Oct 2012
BESIDE RESPIRATORY PATIENT MONITORING SYSTEM BESIDE RESIRATORY PATIENT MONITORING SYSTEM WITH RESPIRATION RATE SOFTWARE
K121806 · Covidien · Sep 2012
MASIMO SET AND MASIMO RAINBOW SET PULSE OXIMETERS AND SENSORS
K120657 · Masimo Corporation · Sep 2012