Cleared Special

K232767 - Nautilus VF ECMO Oxygenator (FDA 510(k) Clearance)

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

K232767 · Mc3, Inc. · Cardiovascular device
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Oct 2023
Decision
23d
Days
Class 2
Risk

K232767 is an FDA 510(k) clearance for the Nautilus VF ECMO Oxygenator. Classified as Oxygenator, Long Term Support Greater Than 6 Hours (product code BYS), Class II - Special Controls.

Submitted by Mc3, Inc. (Dexter, US). The FDA issued a Cleared decision on October 4, 2023 after a review of 23 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4100 - 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 Mc3, Inc. devices

Submission Details

510(k) Number K232767 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 2023
Decision Date October 04, 2023
Days to Decision 23 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
102d faster than avg
Panel avg: 125d · This submission: 23d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code BYS Oxygenator, Long Term Support Greater Than 6 Hours
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4100
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.