Cleared Special

K061442 - PULSE OXIMETER, MODEL PM-50 (FDA 510(k) Clearance)

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

K061442 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Anesthesiology device

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Sep 2006

Decision

104d

Days

Class 2

Risk

K061442 is an FDA 510(k) clearance for the PULSE OXIMETER, MODEL PM-50. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (Great Neck, US). The FDA issued a Cleared decision on September 5, 2006 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 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. devices

Submission Details

510(k) Number	K061442 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	May 24, 2006
Decision Date	September 05, 2006
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.