Masimo

⚠️ High Risk

FEI: 3010074107 • Parque Industrial Palac • MEXICO

FEI

FEI Number

3010074107

📍

Location

Parque Industrial Palac

🇲🇽

Country

MEXICO

🏢

Address

Calz Del Oro 2001, , Parque Industrial Palac, , Mexico

High Risk

FDA Import Risk Assessment

60.5

LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

Total Refusals

Unique Violations

12/18/2023

Latest Refusal

2/12/2020

Earliest Refusal

Score Breakdown

Violation Severity

49.8×40%

Refusal Volume

62.9×30%

Recency

58.5×20%

Frequency

100.0×10%

How is this score calculated?

Proprietary Algorithm

40% Violation Severity — AI-assessed (1-10)
30% Refusal Volume — Logarithmic scale
20% Recency — Decays over 5 years
10% Frequency — Refusals per year

Violation Summary

328049×

FRNMFGREG

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.

11827×

NOT LISTED

It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

3413×

REGISTERED

It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).

5082×

NO 510(K)

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.

Refusal History

Date	Product	Violations	Division
12/18/2023	74MWIMONITOR, PHYSIOLOGICAL, PATIENT (WITHOUT ARRHYTHMIA DETECTION OR ALARMS)	3280FRNMFGREG	Division of West Coast Imports (DWCI)
12/18/2023	74MWIMONITOR, PHYSIOLOGICAL, PATIENT (WITHOUT ARRHYTHMIA DETECTION OR ALARMS)	3280FRNMFGREG	Division of West Coast Imports (DWCI)
12/18/2023	74MWIMONITOR, PHYSIOLOGICAL, PATIENT (WITHOUT ARRHYTHMIA DETECTION OR ALARMS)	3280FRNMFGREG	Division of West Coast Imports (DWCI)
12/18/2023	74MWIMONITOR, PHYSIOLOGICAL, PATIENT (WITHOUT ARRHYTHMIA DETECTION OR ALARMS)	3280FRNMFGREG	Division of West Coast Imports (DWCI)
12/18/2023	74MWIMONITOR, PHYSIOLOGICAL, PATIENT (WITHOUT ARRHYTHMIA DETECTION OR ALARMS)	3280FRNMFGREG	Division of West Coast Imports (DWCI)
12/18/2023	73BZQMONITOR, BREATHING FREQUENCY	3280FRNMFGREG	Division of West Coast Imports (DWCI)
12/18/2023	74MWIMONITOR, PHYSIOLOGICAL, PATIENT (WITHOUT ARRHYTHMIA DETECTION OR ALARMS)	3280FRNMFGREG	Division of West Coast Imports (DWCI)
12/18/2023	74MWIMONITOR, PHYSIOLOGICAL, PATIENT (WITHOUT ARRHYTHMIA DETECTION OR ALARMS)	3280FRNMFGREG	Division of West Coast Imports (DWCI)
12/18/2023	74MWIMONITOR, PHYSIOLOGICAL, PATIENT (WITHOUT ARRHYTHMIA DETECTION OR ALARMS)	3280FRNMFGREG	Division of West Coast Imports (DWCI)
12/18/2023	73BZQMONITOR, BREATHING FREQUENCY	3280FRNMFGREG	Division of West Coast Imports (DWCI)
12/11/2023	73DQAOXIMETER	3280FRNMFGREG	Division of Northern Border Imports (DNBI)
12/11/2023	73DQAOXIMETER	3280FRNMFGREG	Division of Northern Border Imports (DNBI)
12/11/2023	73DQAOXIMETER	3280FRNMFGREG	Division of Northern Border Imports (DNBI)
12/11/2023	73DQAOXIMETER	3280FRNMFGREG	Division of Northern Border Imports (DNBI)
12/11/2023	73DQAOXIMETER	3280FRNMFGREG	Division of Northern Border Imports (DNBI)
12/11/2023	73DQAOXIMETER	3280FRNMFGREG	Division of Northern Border Imports (DNBI)
12/11/2023	73DQAOXIMETER	3280FRNMFGREG	Division of Northern Border Imports (DNBI)
12/11/2023	73DQAOXIMETER	3280FRNMFGREG	Division of Northern Border Imports (DNBI)
12/11/2023	74MWIMONITOR, PHYSIOLOGICAL, PATIENT (WITHOUT ARRHYTHMIA DETECTION OR ALARMS)	3280FRNMFGREG	Division of Northern Border Imports (DNBI)
1/20/2022	73DQAOXIMETER	118NOT LISTED 3280FRNMFGREG	Division of Northern Border Imports (DNBI)
1/20/2022	84OLWINDEX-GENERATING ELECTROENCEPHALOGRAPH SOFTWARE	118NOT LISTED 3280FRNMFGREG	Division of Northern Border Imports (DNBI)
1/20/2022	74MWIMONITOR, PHYSIOLOGICAL, PATIENT (WITHOUT ARRHYTHMIA DETECTION OR ALARMS)	118NOT LISTED 3280FRNMFGREG	Division of Northern Border Imports (DNBI)
11/17/2021	73DQAOXIMETER	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
11/17/2021	84GWQELECTROENCEPHALOGRAPH	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
6/24/2021	84GWQELECTROENCEPHALOGRAPH	118NOT LISTED 3280FRNMFGREG	Division of Northern Border Imports (DNBI)
6/24/2021	74MUDOXIMETER, TISSUE SATURATION	118NOT LISTED 3280FRNMFGREG	Division of Northern Border Imports (DNBI)
6/24/2021	74MUDOXIMETER, TISSUE SATURATION	118NOT LISTED 3280FRNMFGREG	Division of Northern Border Imports (DNBI)
6/24/2021	73DQAOXIMETER	118NOT LISTED 3280FRNMFGREG	Division of Northern Border Imports (DNBI)
6/24/2021	73DQAOXIMETER	118NOT LISTED 3280FRNMFGREG	Division of Northern Border Imports (DNBI)
6/24/2021	73DQAOXIMETER	118NOT LISTED 3280FRNMFGREG	Division of Northern Border Imports (DNBI)
6/24/2021	84GWQELECTROENCEPHALOGRAPH	118NOT LISTED 3280FRNMFGREG	Division of Northern Border Imports (DNBI)
6/24/2021	84GWQELECTROENCEPHALOGRAPH	118NOT LISTED 3280FRNMFGREG	Division of Northern Border Imports (DNBI)
6/24/2021	73DQAOXIMETER	118NOT LISTED 3280FRNMFGREG	Division of Northern Border Imports (DNBI)
6/24/2021	73DQAOXIMETER	118NOT LISTED 3280FRNMFGREG	Division of Northern Border Imports (DNBI)
6/24/2021	73DQAOXIMETER	118NOT LISTED 3280FRNMFGREG	Division of Northern Border Imports (DNBI)
6/24/2021	73DQAOXIMETER	118NOT LISTED 3280FRNMFGREG	Division of Northern Border Imports (DNBI)
6/24/2021	73DQAOXIMETER	118NOT LISTED 3280FRNMFGREG	Division of Northern Border Imports (DNBI)
6/24/2021	73DQAOXIMETER	118NOT LISTED 3280FRNMFGREG	Division of Northern Border Imports (DNBI)
6/24/2021	73DQAOXIMETER	118NOT LISTED 3280FRNMFGREG	Division of Northern Border Imports (DNBI)
6/24/2021	73DQAOXIMETER	118NOT LISTED 3280FRNMFGREG	Division of Northern Border Imports (DNBI)
6/24/2021	73DQAOXIMETER	118NOT LISTED 3280FRNMFGREG	Division of Northern Border Imports (DNBI)
6/24/2021	84OLWINDEX-GENERATING ELECTROENCEPHALOGRAPH SOFTWARE	118NOT LISTED 3280FRNMFGREG	Division of Northern Border Imports (DNBI)
6/24/2021	74MWIMONITOR, PHYSIOLOGICAL, PATIENT (WITHOUT ARRHYTHMIA DETECTION OR ALARMS)	118NOT LISTED 3280FRNMFGREG	Division of Northern Border Imports (DNBI)
6/24/2021	74MWIMONITOR, PHYSIOLOGICAL, PATIENT (WITHOUT ARRHYTHMIA DETECTION OR ALARMS)	118NOT LISTED 3280FRNMFGREG	Division of Northern Border Imports (DNBI)
6/24/2021	73DQAOXIMETER	118NOT LISTED 3280FRNMFGREG	Division of Northern Border Imports (DNBI)
6/24/2021	73DQAOXIMETER	118NOT LISTED 3280FRNMFGREG	Division of Northern Border Imports (DNBI)
2/12/2020	84GWQELECTROENCEPHALOGRAPH	3280FRNMFGREG 341REGISTERED	Division of Northern Border Imports (DNBI)
2/12/2020	73DQAOXIMETER	3280FRNMFGREG 341REGISTERED	Division of Northern Border Imports (DNBI)
2/12/2020	73DQAOXIMETER	3280FRNMFGREG 341REGISTERED	Division of Northern Border Imports (DNBI)

Frequently Asked Questions

What is Masimo's FDA import refusal history?

Masimo (FEI: 3010074107) has 49 FDA import refusal record(s) in our database, spanning from 2/12/2020 to 12/18/2023.

What is an FEI number?

FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. Masimo's FEI number is 3010074107.

What types of violations has Masimo received?

Masimo has been cited for 4 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.

Where does this information about Masimo come from?

All FDA import refusal data for Masimo is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.

Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.