Cleared Traditional

K232385 - OxiplexTS200 (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K232385 · Iss Medical, Inc. · General & Plastic Surgery device
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Mar 2024
Decision
205d
Days
Class 2
Risk

K232385 is an FDA 510(k) clearance for the OxiplexTS200. Classified as Oximeter, Tissue Saturation (product code MUD), Class II - Special Controls.

Submitted by Iss Medical, Inc. (Champaign, US). The FDA issued a Cleared decision on March 1, 2024 after a review of 205 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 Iss Medical, Inc. devices

Submission Details

510(k) Number K232385 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 2023
Decision Date March 01, 2024
Days to Decision 205 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
91d slower than avg
Panel avg: 114d · This submission: 205d
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 72
Devices cleared under the same product code (MUD) and FDA review panel - the closest regulatory comparables to K232385.
Masimo O3 Regional Oximeter
K243324 · Masimo Corporation · Jul 2025
Lap.Ox™ Laparoscopic Tissue Oximeter
K250519 · Vioptix, Inc. · Jun 2025
Cerebral Autoregulation Index (CAI) Algorithm
K240596 · Edwards Lifesciences · Oct 2024
ODI-Tech
K241393 · Odi Medical AS · Aug 2024
SnapshotNIR model KD205
K240601 · Kent Imaging, Inc. · Apr 2024
Intra.Ox™ 2.0 Handheld Tissue Oximeter
K233488 · Vioptix, Inc. · Feb 2024