510(k) Report

510(k) · Cleared

Cleared

Nautilus VF ECMO Oxygenator

K232767510(k) SpecialCleared Oct 4, 202323-day reviewClass II21 CFR 870.4100

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Mc3, Inc. · BYS Oxygenator, Long Term Support Greater Than 6 Hours

Cleared on Oct 4, 2023 as substantially equivalent to K191935 (Mc3 Incorporated, 2020) after a 23-day review. Its family tree reaches back 1 generation to 2020.

Decided
Oct 4, 2023
Review
23 days
Class
Class II
Product code
BYS
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K191935 (2020). No later device cites it as a predicate yet.

K191935 · Nautilus Smart ECMO Module · Mc3 Incorporated · 2020 · recalled202020222024
K191935 · Nautilus Smart ECMO Module · Mc3 Incorporated · 2020 · recalled0
  1. Root · 1 generation backK191935 Nautilus Smart ECMO ModuleMc3 Incorporated · 2020 · Recalled
  2. This deviceK232767 Nautilus VF ECMO OxygenatorMc3, Inc. · 2023
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K191935Nautilus Smart ECMO ModuleMc3 Incorporated20202
0 (this device)K232767Nautilus VF ECMO OxygenatorMc3, Inc.2023—
FIG. 1 — Lineage of K232767, 2020–2023Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in BYS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K191935Nautilus Smart ECMO Module
Summary page 4
…21 CFR 870.4100 Product Code: BYS Predicate: Nautilus™ Smart ECMO Module (K191935) Nautilus™ ECMO Oxygenator (K191935) Indications for Use: The NautilusTM VF ECM…
Mc3 Incorporated20202

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has a recall.

How does its category compare?

All BYS devices

BYS Oxygenator, Long Term Support Greater Than 6 Hours: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.

FDA decisions per year · BYS

1in 2023

2020: 12023: 1
2007high 1 (2020) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · BYS

Too few BYS 510(k)s in any year since 2007 to give a median.

Recalls per year · BYS

No recall names BYS since 2007.

Adverse event reports per year · BYS

60in 2025

2007: 92020: 12021: 52022: 22023: 202024: 422025: 60
2007high 60 (2025) · low 0 (2008)2025

MAUDE reports naming product code BYS, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—09
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20201—01
20210—05
20220—02
20231—020
20240—042
20250—060
20260—0—

What is it indicated for?

The Nautilus VF ECMO Oxygenator with integrated heat exchanger is intended to provide assisted

long-term extracorporeal circulation and physiologic gas exchange (oxygenation and carbon dioxide

removal) of the patient's blood for up to 48 hours in adult and pediatric adolescent patients with

acute respiratory failure or acute cardiopulmonary failure, where other available treatment options

have failed, and continued clinical deterioration is expected or the risk of death is imminent. The

integrated heat exchanger is intended to heat or cool the blood as needed during use. Integrated

fluid path pressure, temperature, and oxygen saturation monitoring is achieved by built-in sensor

modules.

Indications for use as stated in the FDA summary.

More from Mc3, Inc.

2 FDA decisions under this applicant name. See the company

  • K203409MC3 Crescent Jugular Dual Lumen CatheterMc3, Inc. · 2021

Recent decisions in BYS

The BYS category page

  • K191935Nautilus Smart ECMO ModuleMc3 Incorporated · 20202 recalls
  • K770720Tubing Pack, Extracorporeal, H-3000William Harvey Life Products Corp. · 1977

https://510kreport.com/device/K232767 · printed Nov 5, 2026

Cite this page

510(k) Report. “K232767: Nautilus VF ECMO Oxygenator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K232767

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026