Cleared Special

Clarifi Imaging System (K181623) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K181623 · Modulated Imaging, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2018
Decision
29d
Days
Class 2
Risk

K181623 is an FDA 510(k) clearance for the Clarifi Imaging System. Classified as Oximeter, Tissue Saturation (product code MUD), Class II - Special Controls.

Submitted by Modulated Imaging, Inc. (Irvine, US). The FDA issued a Cleared decision on July 19, 2018 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2700 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Modulated Imaging, Inc. devices

Submission Details

510(k) Number K181623 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 2018
Decision Date July 19, 2018
Days to Decision 29 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
96d faster than avg
Panel avg: 125d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code MUD Oximeter, Tissue Saturation
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 Cardiovascular devices follow this clearance model.

Regulatory Consultant

O’Connell Regulatory Consultants, Inc.
Maureen O'Connell

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - MUD Oximeter, Tissue Saturation

All 26
Devices cleared under the same product code (MUD) and FDA review panel - the closest regulatory comparables to K181623.
SenSmart Model 8006CA Reusable Regional Oximetry Sensor, SenSmart Model 8006PI Disposable Patient Interface
K190560 · Nonin Medical, Inc. · May 2019
INVOS PM7100 Patient Monitor, INVOS Adult rSO2 Sensor
K182868 · Covidien, LLC · Jan 2019
Presygen/si-1
K171245 · Christie Medical Holdings, Inc. · Aug 2018
FORE-SIGHT ELITE Module Tissue Oximeter
K180003 · Cas Medical Systems, Inc. · May 2018
Masimo O3 Regional Oximeter System
K162603 · Masimo Corporation · May 2017