Cleared Traditional

K070371 - FINGERTIP PULSE OXIMETER MD300C

K070371 is an FDA 510(k) clearance for FINGERTIP PULSE OXIMETER MD300C, 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 186-day FDA review.

K070371 · Beijing Choice Electronic Technololgy Co., Ltd. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2007
Decision
186d
Days
Class 2
Risk

K070371 is an FDA 510(k) clearance for the FINGERTIP PULSE OXIMETER MD300C. 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 August 13, 2007 after a review of 186 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 - K070371

510(k) Number K070371 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 2007
Decision Date August 13, 2007
Days to Decision 186 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
46d slower than avg
Panel avg: 140d · This submission: 186d
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 614
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K070371.
PM-50 PULSE OXIMETER AND VS-800 VITAL SIGNS MONITOR
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K072295 · Oridion Capnography, Inc. · Oct 2007
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DIGITAL PULSE OXIMETER, MODEL 7500FO
K071415 · Nonin Medical, Inc. · Aug 2007
PC-60, NON-INVASIVEPULSE OXIMETER
K063641 · Shenzhen Creative Industry Co., Ltd. · Jul 2007
DIGITAL PULSE OXIMETER, MODEL 7500
K071285 · Nonin Medical, Inc. · Jul 2007