Cleared Traditional

K131111 - IHEALTH FINGERTIP PULSE OXIMETER

K131111 is an FDA 510(k) clearance for IHEALTH FINGERTIP PULSE OXIMETER, manufactured by Andon Health Co, Ltd.. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Traditional 510(k) pathway after a 145-day FDA review.

K131111 · Andon Health Co, Ltd. · Anesthesiology device
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Sep 2013
Decision
145d
Days
Class 2
Risk

K131111 is an FDA 510(k) clearance for the IHEALTH FINGERTIP PULSE OXIMETER. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Andon Health Co, Ltd. (Tianjin, CN). The FDA issued a Cleared decision on September 11, 2013 after a review of 145 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 Andon Health Co, Ltd. devices

FDA 510(k) Submission Details - K131111

510(k) Number K131111 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 2013
Decision Date September 11, 2013
Days to Decision 145 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
5d slower than avg
Panel avg: 140d · This submission: 145d
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 477
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K131111.
FINGERTIP PULSE OXIMETER
K130947 · Beijing Choice Electronic Technololgy Co., Ltd. · Oct 2013
TRUSIGNAL SPO2 ADULT AND PEDIATRIC ADHESIVE WRAP DISPOSABLE SENSOR
K132696 · GE Healthcare Finland Oy · Sep 2013
PULSE OXIMETER
K131021 · Nonin Medical, Inc. · Sep 2013
VITAL SIGNS MONITOR
K131818 · Edan Instruments, Inc. · Aug 2013
FINGERTIP PULSE OXIMETER
K123871 · Beijing Choice Electronic Technololgy Co., Ltd. · May 2013
MASIMO RAS-125C ACOUSTIC RESPIRATION SENSOR
K120984 · Masimo Corporation · Apr 2013