Cleared Traditional

QMAPP? (Hemo, Hemo Lite, PCM, GO, Hybrid)

K241766 · Fysicon BV · Cardiovascular

Aug 2025

Decision

433d

Days

Class 2

Risk

About This 510(k) Submission

K241766 is an FDA 510(k) clearance for the QMAPP? (Hemo, Hemo Lite, PCM, GO, Hybrid), a Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) (Class II — Special Controls, product code MWI), submitted by Fysicon BV (Oss, NL). The FDA issued a Cleared decision on August 27, 2025, 433 days after receiving the submission on June 20, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2300.

Submission Details

510(k) Number	K241766 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 20, 2024
Decision Date	August 27, 2025
Days to Decision	433 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF

Device Classification

Product Code	MWI — Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 870.2300