Cleared Traditional

K100203 - HANDHELD PULSE OXIMETER MODEL MD300A/ M...

K100203 is the FDA 510(k) clearance for HANDHELD PULSE OXIMETER MODEL MD300A/ M... 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 112-day FDA review.

K100203 · Beijing Choice Electronic Technololgy Co., Ltd. · Anesthesiology device
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May 2010
Decision
112d
Days
Class 2
Risk

K100203 is an FDA 510(k) clearance for the HANDHELD PULSE OXIMETER MODEL MD300A/ MD300K2/ MD300M. 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 May 17, 2010 after a review of 112 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 K100203 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 2010
Decision Date May 17, 2010
Days to Decision 112 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
28d faster than avg
Panel avg: 140d · This submission: 112d
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 401
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