Cleared Traditional

K143396 - omni TRAX Active Patient Tracker

K143396 is an FDA 510(k) clearance for omni TRAX Active Patient Tracker, manufactured by Civco Medical Instruments CO Inc Dba Civco Medical Solutions. The device is a Class 2 Radiology device with product code IYO cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K143396 · Civco Medical Instruments CO Inc Dba Civco Medical Solutions · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2015
Decision
58d
Days
Class 2
Risk

K143396 is an FDA 510(k) clearance for the omni TRAX Active Patient Tracker. Classified as System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), Class II - Special Controls.

Submitted by Civco Medical Instruments CO Inc Dba Civco Medical Solutions (Kalona, US). The FDA issued a Cleared decision on January 23, 2015 after a review of 58 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1560 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Civco Medical Instruments CO Inc Dba Civco Medical Solutions devices

FDA 510(k) Submission Details - K143396

510(k) Number K143396 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 2014
Decision Date January 23, 2015
Days to Decision 58 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 107d · This submission: 58d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IYO Device Classification - Class 2, Special Controls

Product Code IYO System, Imaging, Pulsed Echo, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1560
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 Radiology devices follow this clearance model.

Regulatory Peers - IYO System, Imaging, Pulsed Echo, Ultrasonic

All 490
Devices cleared under the same product code (IYO) and FDA review panel - the closest regulatory comparables to K143396.
Site-Rite Prevue Ultrasound System, Site-Rite Prevue+ Ultrasound System
K150529 · C.R. Bard, Inc. · Mar 2015
Volcano iFR Modality, iFR Scout feature
K150441 · Volcano Corporation · Mar 2015
Volcano iFR Harvest Software (Offline)
K143122 · Volcano Corporation · Feb 2015
Site-Rite 6 Ultrasound System with Pinpoint GT Technology
K142443 · C.R. Bard, Inc. · Oct 2014
SC2000 and ACUSON X300 Diagnostic Ultrasound Systems
K142395 · Siemens Medical Solutions USA, Inc. · Sep 2014
VOLCANO IFR MODALITY
K133323 · Volcano Corporation · Mar 2014