Cleared Traditional

K072581 - PM-60 PULSE OXIMETER

K072581 is an FDA 510(k) clearance for PM-60 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 Traditional 510(k) pathway after a 117-day FDA review.

K072581 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Anesthesiology device
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Jan 2008
Decision
117d
Days
Class 2
Risk

K072581 is an FDA 510(k) clearance for the PM-60 PULSE OXIMETER. 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 January 8, 2008 after a review of 117 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 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. devices

FDA 510(k) Submission Details - K072581

510(k) Number K072581 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 2007
Decision Date January 08, 2008
Days to Decision 117 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
23d faster than avg
Panel avg: 140d · This submission: 117d
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 581
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K072581.
FORE-SIGHT, MC-2000 SERIES
K073036 · Cas Medical Systems, Inc. · Feb 2008
MASIMO RAINBOW SET RAD 87 PULSE CO-OXIMETER AND ACCESSORIES
K073024 · Masimo Corporation · Feb 2008
FINGERTIP PULSE OXIMETER, MODEL MD300I
K072825 · Beijing Choice Electronic Technololgy Co., Ltd. · Jan 2008
PM-50 PULSE OXIMETER AND VS-800 VITAL SIGNS MONITOR
K072235 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Oct 2007
FINGERTIP PULSE OXIMETER MD300C
K070371 · Beijing Choice Electronic Technololgy Co., Ltd. · Aug 2007
DIGITAL PULSE OXIMETER, MODEL 7500FO
K071415 · Nonin Medical, Inc. · Aug 2007