Cleared Abbreviated

K160582 - WiCap

K160582 is the FDA 510(k) clearance for WiCap by Athena Gtx. It is a Class 2 Anesthesiology device (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

Submission Details

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
Regulatory Context
Review time vs. panel average
45d slower than avg
Panel avg: 140d · This submission: 185d
Pathway characteristics
Standards-based clearance path.

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 369
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K160582.
Masimo Rainbow SET Intellivue Module Pulse CO-Oximeter
K162675 · Masimo Corporation · Dec 2016
Model X-100C CO-Met™ Oximetry System
K160231 · Nonin Medical, Inc. · Dec 2016
Masimo Disposable Transflectance Forehead Sensor
K160940 · Masimo Corporation · Nov 2016
Model 6100C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6100C Series: 6100CA, 6100CP, 6100CI, 6100CN), Model 6101C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6101C Series: 6101CA, 6101CP, 6101CI, 6101CN), Model 6102C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6102C Series: 6102CA, 6102CP, 6102CI, 6102CN), Model 8100AA/8100AP Reusable, Finger Clip Pulse Oximeter Sensor, Model 8101AA/8101AP Reusable, Finger Clip Pulse Oximeter Senso
K160865 · Nonin Medical, Inc. · Aug 2016
Finger Type Pulse Oximeter
K151024 · Taidoc Technology Corporation · Mar 2016
Masimo MightySat Rx Fingertip Pulse Oximeter
K150314 · Masimo Corporation · Oct 2015