Cleared Traditional

K141362 - PULSE OXIMETER CMS50EW

K141362 is an FDA 510(k) clearance for PULSE OXIMETER CMS50EW, manufactured by Contec Medical Systems Co.,Ltd. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Traditional 510(k) pathway after a 335-day FDA review.

K141362 · Contec Medical Systems Co.,Ltd · Anesthesiology device
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Apr 2015
Decision
335d
Days
Class 2
Risk

K141362 is an FDA 510(k) clearance for the PULSE OXIMETER CMS50EW. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Contec Medical Systems Co.,Ltd (Shanghai, CN). The FDA issued a Cleared decision on April 23, 2015 after a review of 335 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Contec Medical Systems Co.,Ltd devices

FDA 510(k) Submission Details - K141362

510(k) Number K141362 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 2014
Decision Date April 23, 2015
Days to Decision 335 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
195d slower than avg
Panel avg: 140d · This submission: 335d
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 454
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K141362.
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K142888 · Beijing Choice Electronic Technololgy Co., Ltd. · Feb 2015