Cleared Special

FINGERTIP PULSE OXIMETER, MODEL MD300I (K072825) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K072825 · Beijing Choice Electronic Technololgy Co., Ltd. · Anesthesiology device
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Jan 2008
Decision
104d
Days
Class 2
Risk

K072825 is an FDA 510(k) clearance for the FINGERTIP PULSE OXIMETER, MODEL MD300I. 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 14, 2008 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Beijing Choice Electronic Technololgy Co., Ltd. devices

Submission Details

510(k) Number K072825 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 2007
Decision Date January 14, 2008
Days to Decision 104 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 139d · This submission: 104d
Pathway characteristics
Modification to existing cleared device.

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 146
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