DeviceClearance

Product code MWI— Cardiovascular

M2376A DEVICELINK SYSTEM

Classification name
Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Device class
Class 2
Regulation
21 CFR 870.2300
Advisory panel
Cardiovascular
Total cleared
308
First cleared
Most recent

Market context for product code MWI

FDA has cleared 308 devices under product code MWI between 1999 and 2026, filed by 136 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

last 15 years

Top applicants under product code MWI

Adverse events under product code MWI

product code MWI
Death
16
Malfunction
963
Total
979

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code MWI

1–100 of 308

Data sourced from openFDA. This site is unofficial and independent of the FDA.