MouthLab Vital Signs Monitoring System— 510(k) K201635

Name: FDA 510(k) clearance K201635
Creator: U.S. Food and Drug Administration
Published: 2021-02-06

Substantially Equivalent

Multisensor Diagnostics (Dba Aidar Health)

FDA 510(k) clearance K201635 for MouthLab Vital Signs Monitoring System, Substantially Equivalent on 2021-02-06. Applicant: Multisensor Diagnostics (Dba Aidar Health). Device class: 2.

Clearance details

Applicant: Multisensor Diagnostics (Dba Aidar Health)
Product code: Code MWI
Device class: Class 2
Regulation: 21 CFR 870.2300
Advisory panel: Cardiovascular
Date received: 2020-06-16
Decision date: 2021-02-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pikesville, MD, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MWI

view all

K260438 — Vital Signs Monitor (CLEO2)2026-08-14
K253417 — Masimo Root Monitoring System2026-08-12
K253196 — Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400)2026-06-12
K253436 — c-med0 alpha2026-04-30
K250135 — WAVE Clinical Platform (2.0.000)2026-01-16

Adverse events under product code MWI

product code MWI

Death: 16
Malfunction: 963
Total: 979

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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