Cleared Abbreviated

PC-60NW FINGERTIP OXIMETER (K120502) - FDA 510(k) Clearance

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

K120502 · Shenzhen Creative Industry Co., Ltd. · Anesthesiology device
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Dec 2012
Decision
290d
Days
Class 2
Risk

K120502 is an FDA 510(k) clearance for the PC-60NW FINGERTIP OXIMETER. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Shenzhen Creative Industry Co., Ltd. (Echo, US). The FDA issued a Cleared decision on December 7, 2012 after a review of 290 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Shenzhen Creative Industry Co., Ltd. devices

Submission Details

510(k) Number K120502 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 2012
Decision Date December 07, 2012
Days to Decision 290 days
Submission Type Abbreviated
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
150d slower than avg
Panel avg: 140d · This submission: 290d
Pathway characteristics
Standards-based clearance path.

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 189
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Finger Type Pulse Oximeter
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