Cleared Special

K061442 - PULSE OXIMETER, MODEL PM-50

K061442 is an FDA 510(k) clearance for PULSE OXIMETER, manufactured by Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Special 510(k) pathway after a 104-day FDA review.

K061442 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K061442

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 140d · This submission: 104d
Pathway characteristics
Modification to existing cleared device.

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 726
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K061442 · PULSE OXIMETER, MODEL PM-50
Download PDF FDA Summary Shenzhen Mindray Bio-…