Cleared Traditional

CMO8 Adult PMP Oxygenator with Tubing Pack (Model: CME40009) (K231414) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K231414 · Chalice Medical , Ltd. · Cardiovascular device
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Nov 2023
Decision
169d
Days
Class 2
Risk

K231414 is an FDA 510(k) clearance for the CMO8 Adult PMP Oxygenator with Tubing Pack (Model: CME40009). Classified as Oxygenator, Cardiopulmonary Bypass (product code DTZ), Class II - Special Controls.

Submitted by Chalice Medical , Ltd. (Worksop, GB). The FDA issued a Cleared decision on November 1, 2023 after a review of 169 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4350 - the FDA cardiovascular device 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Chalice Medical , Ltd. devices

Submission Details

510(k) Number K231414 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 2023
Decision Date November 01, 2023
Days to Decision 169 days
Submission Type Traditional
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
44d slower than avg
Panel avg: 125d · This submission: 169d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DTZ Oxygenator, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4350
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 Peers - DTZ Oxygenator, Cardiopulmonary Bypass

All 97
Devices cleared under the same product code (DTZ) and FDA review panel - the closest regulatory comparables to K231414.
Affinity NT Oxygenator and Uncoated Cardiotomy/ Venous Reservoir (541)
K241352 · Medtronic, Inc. · Jun 2024
D100 KIDS
K231652 · Sorin Group Italia S.R.L. · Nov 2023
Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT75-C1U, Quantum Perfusion Blood Oxygenator with Integrated AF VT75-C2U, Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT200-C1U, Quantum Perfusion Blood Oxygenator with Integrated AF VT200-C2U, Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT160-C1U
K231773 · Qura S.R.L · Nov 2023
Affinity Fusion™ Oxygenator System
K230640 · Medtronic, Inc. · Apr 2023
OXY-1 System
K223161 · Abiomed, Inc. · Feb 2023
CentriMag Pre-connected Pack
K222297 · Abbott · Dec 2022