Cleared Abbreviated

K121820 - INWAVE

K121820 is an FDA 510(k) clearance for INWAVE, manufactured by Zynex Medical, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KPI cleared through the Abbreviated 510(k) pathway after a 64-day FDA review.

K121820 · Zynex Medical, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2012
Decision
64d
Days
Class 2
Risk

K121820 is an FDA 510(k) clearance for the INWAVE. Classified as Stimulator, Electrical, Non-implantable, For Incontinence (product code KPI), Class II - Special Controls.

Submitted by Zynex Medical, Inc. (Lone Tree, US). The FDA issued a Cleared decision on August 24, 2012 after a review of 64 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5320 - the FDA gastroenterology and urology 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 Zynex Medical, Inc. devices

FDA 510(k) Submission Details - K121820

510(k) Number K121820 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 2012
Decision Date August 24, 2012
Days to Decision 64 days
Submission Type Abbreviated
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
67d faster than avg
Panel avg: 131d · This submission: 64d
Pathway characteristics
Standards-based clearance path.

KPI Device Classification - Class 2, Special Controls

Product Code KPI Stimulator, Electrical, Non-implantable, For Incontinence
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5320
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 Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - KPI Stimulator, Electrical, Non-implantable, For Incontinence

All 87
Devices cleared under the same product code (KPI) and FDA review panel - the closest regulatory comparables to K121820.
INTONEMV
K134020 · Incontrol Medical, LLC · Feb 2014
INTONEMV
K133826 · Incontrol Medical, LLC · Jan 2014
LIFE-CARE VAGINAL PROBE LIFE-CARE ANAL PROBE
K122194 · Everyway Medical Instruments Co.,Ltd · Apr 2013
INCONTROL
K110179 · Incontrol Medical, LLC · Feb 2012
TENSCARE ITOUCH SURE MODEL ITS
K103698 · Tenscare, Ltd. · Jun 2011
OMNISTIM CONTINENCE+ PELVIC FLOOR STIMULATION SYSTEM
K093600 · Accelerated Care Plus · Dec 2009