Cleared Special

K082641 - FINGERTIP PULSE OXIMETER

K082641 is the FDA 510(k) clearance for FINGERTIP PULSE OXIMETER by Contec Medical System Co., Ltd.. It is a Class 2 Anesthesiology device (product code DQA) cleared through the Special 510(k) pathway after a 60-day FDA review.

K082641 · Contec Medical System Co., Ltd. · Anesthesiology device
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Nov 2008
Decision
60d
Days
Class 2
Risk

K082641 is an FDA 510(k) clearance for the FINGERTIP PULSE OXIMETER, MODELS CMS-50D, CMS-50L, CMS-50DL. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Contec Medical System Co., Ltd. (Zhong Shan, Shanghai, CN). The FDA issued a Cleared decision on November 10, 2008 after a review of 60 days - a notably fast clearance cycle.

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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Contec Medical System Co., Ltd. devices

Submission Details

510(k) Number K082641 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 2008
Decision Date November 10, 2008
Days to Decision 60 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
80d faster than avg
Panel avg: 140d · This submission: 60d
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 368
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K082641.
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K081659 · Masimo Corporation · Sep 2008