Cleared Traditional

Med-Link Temp-pulse Oximeter (K202743) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K202743 · Shenzhen Med-Link Electronics Tech Co., Ltd. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2021
Decision
164d
Days
Class 2
Risk

K202743 is an FDA 510(k) clearance for the Med-Link Temp-pulse Oximeter. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Shenzhen Med-Link Electronics Tech Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on March 1, 2021 after a review of 164 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 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 Med-Link Electronics Tech Co., Ltd. devices

Submission Details

510(k) Number K202743 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 2020
Decision Date March 01, 2021
Days to Decision 164 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
24d slower than avg
Panel avg: 140d · This submission: 164d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 172
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K202743.
Fingertip Pulse Oximeter
K210274 · Zhuhai Linte Medical Instrument Co., Ltd. · Jul 2021
VS Newborn Heart Rate Monitor
K201887 · Surepulse Medical Limited · Jul 2021
Pulse Oximeter
K203854 · Shenzhen Hexin Zondan Medical Equipment Co., Ltd. · Apr 2021
Fingertip pulse oximeter
K202776 · Shenzhen Lepu Intelligent Medical Equipment Co., Ltd. · Mar 2021
Pulse Oximeter
K201468 · Shenzhen Creative Industry Co., Ltd. · Jan 2021
Fingertip Pulse Oximeter
K202324 · Shenzhen Bsx Technology Electronics Co., Ltd. · Dec 2020