Cleared Special

Intra.Ox 2.0 Handheld Tissue Oximeter (K221010) - FDA 510(k) Clearance

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

K221010 · Vioptix, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2022
Decision
28d
Days
Class 2
Risk

K221010 is an FDA 510(k) clearance for the Intra.Ox 2.0 Handheld Tissue Oximeter. Classified as Oximeter, Tissue Saturation (product code MUD), Class II - Special Controls.

Submitted by Vioptix, Inc. (Newark, US). The FDA issued a Cleared decision on May 3, 2022 after a review of 28 days - a notably fast clearance 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. 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 Vioptix, Inc. devices

Submission Details

510(k) Number K221010 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 2022
Decision Date May 03, 2022
Days to Decision 28 days
Submission Type Special
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
87d faster than avg
Panel avg: 115d · This submission: 28d
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 General & Plastic Surgery devices follow this clearance model.

Regulatory Consultant

ViOptix, Inc.
Mark Lonsinger

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 K221010.
Edwards Algorithm for Measurement of Blood Hemoglobin
K230612 · Edwards Lifesciences, LLC · Nov 2023
Cerebral Adaptive Index (CAI) Algorithm
K223651 · Edwards Lifesciences, LLC · May 2023
Masimo O3 Regional Oximeter System
K214072 · Masimo Corporation · May 2022
INVOS PM7100 Patient Monitor, INVOS Pediatric rSO2 Sensor, INVOS Infant Regional Saturation Sensor (also referred to as OxyAlert NIRSensor)
K211561 · Covidien, LLC · Dec 2021
FORE-SIGHT ELITE Absolute Tissue Oximeter
K203490 · Edwards Lifesciences, LLC · Feb 2021
SnapshotNIR
K201976 · Kent Imaging · Nov 2020