Cleared Traditional

K190334 - MIMOSA Imager

K190334 is the FDA 510(k) clearance for MIMOSA Imager by Mimosa Diagnostics, Inc.. It is a Class 2 General & Plastic Surgery device (product code MUD) cleared through the Traditional 510(k) pathway after a 260-day FDA review.

K190334 · Mimosa Diagnostics, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2019
Decision
260d
Days
Class 2
Risk

K190334 is an FDA 510(k) clearance for the MIMOSA Imager. Classified as Oximeter, Tissue Saturation (product code MUD), Class II - Special Controls.

Submitted by Mimosa Diagnostics, Inc. (Toronto, CA). The FDA issued a Cleared decision on November 1, 2019 after a review of 260 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 870.2700 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Mimosa Diagnostics, Inc. devices

Submission Details

510(k) Number K190334 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 2019
Decision Date November 01, 2019
Days to Decision 260 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
145d slower than avg
Panel avg: 115d · This submission: 260d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - MUD Oximeter, Tissue Saturation

All 31
Devices cleared under the same product code (MUD) and FDA review panel - the closest regulatory comparables to K190334.
FORE-SIGHT ELITE Absolute Tissue Oximeter
K203490 · Edwards Lifesciences, LLC · Feb 2021
SnapshotNIR
K201976 · Kent Imaging · Nov 2020
Masimo O3 Regional Oximeter System
K201432 · Masimo Corporation · Aug 2020
FORE-SIGHT ELITE Tissue Oximeter Module
K190270 · Cas Medical Systems, Inc. · Oct 2019
T-Stat 2.0 Microvascular Tissue Oximeter
K192322 · Spectros Corporation · Sep 2019
Intra.Ox 2.0 Handheld Tissue Oximeter
K191676 · Vioptix, Inc. · Sep 2019