Cleared Abbreviated

K160582 - WiCap

K160582 is an FDA 510(k) clearance for WiCap, manufactured by Athena Gtx. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Abbreviated 510(k) pathway after a 185-day FDA review.

K160582 · Athena Gtx · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2016
Decision
185d
Days
Class 2
Risk

K160582 is an FDA 510(k) clearance for the WiCap. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Athena Gtx (Johnson, US). The FDA issued a Cleared decision on September 2, 2016 after a review of 185 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 Athena Gtx devices

FDA 510(k) Submission Details - K160582

510(k) Number K160582 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 2016
Decision Date September 02, 2016
Days to Decision 185 days
Submission Type Abbreviated
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
45d slower than avg
Panel avg: 140d · This submission: 185d
Pathway characteristics
Standards-based clearance path.

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 577
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K160582.
Fingertip Pulse Oximeter A310
K153021 · Amemo, Inc. · Nov 2016
Fingertip Pulse Oximeter MD300CG11/MD300CG51
K160268 · Beijing Choice Electronic Technology Co., Ltd. · Oct 2016
Fingertip Pulse Oximeter MD300CN310
K161560 · Beijing Choice Electronic Technology Co., Ltd. · Oct 2016
Fingertip Pulse Oximeter
K152091 · Jiangsu Konsung Bio-Medical Science & Technology Co., Ltd. · Aug 2016
Medke Oximetry Finger Sensor
K152390 · Shenzhen Medke Technology Co., Ltd. · Aug 2016
Wrist Pulse Oximeter
K152089 · Jiangsu Konsung Bio-Medical Science & Technology Co., Ltd. · Aug 2016