510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K191935Substantially Equivalent

Nautilus Smart ECMO Module

Mc3 Incorporated, Dexter MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K191935 is the FDA 510(k) clearance record for Nautilus Smart ECMO Module, a class II device, cleared for Mc3 Incorporated on under FDA product code BYS (Oxygenator, Long Term Support Greater Than 6 Hours). FDA records list 4 510(k) clearances for Mc3 Incorporated, from to . As of , FDA records show 2 recalls naming K191935.

Clearance record

Decision date
Received
(265 days to decision)
Product code
BYS Oxygenator, Long Term Support Greater Than 6 Hours
Regulation
21 CFR 870.4100
Device class
Class II
Review panel
Cardiovascular
Applicant
Mc3 Incorporated 2555 Bishop Cir. W, Dexter MI
510(k) summary
Summary PDF
Third party review
No

Clearances, product code BYS

Trailing 12 months

FDA records hold no clearances under product code BYS in the trailing twelve months.

FDA records show no clearances under product code BYS in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code BYS, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260