QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid)— 510(k) K241766

Name: FDA 510(k) clearance K241766
Creator: U.S. Food and Drug Administration
Published: 2025-08-27

Substantially Equivalent

Fysicon BV

FDA 510(k) clearance K241766 for QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid), Substantially Equivalent on 2025-08-27. Applicant: Fysicon BV. Device class: 2.

Clearance details

Applicant: Fysicon BV
Product code: Code MWI
Device class: Class 2
Regulation: 21 CFR 870.2300
Advisory panel: Cardiovascular
Date received: 2024-06-20
Decision date: 2025-08-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oss, NL

Download summary PDF View on FDA.gov ↗

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K253436 — c-med0 alpha2026-04-30
K250135 — WAVE Clinical Platform (2.0.000)2026-01-16

More clearances from Fysicon BV

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K170032 — QMAPP Amplifier; QMAPP Hemodynamic Monitoring System; QMAPP PCM; QMAPP GO; QMAPP EP2017-09-08

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.